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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03154086
Registration number
NCT03154086
Ethics application status
Date submitted
12/05/2017
Date registered
15/05/2017
Date last updated
9/08/2019
Titles & IDs
Public title
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
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Scientific title
A Phase I, First Time in Human, Two Part, Randomized, Placebo-Controlled, Double-Blind (Sponsor Unblind), Single and Repeat Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers
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Secondary ID [1]
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207440
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK3352589
Treatment: Drugs - Matching Placebo
Experimental: Part A: Cohort 1: Placebo/GSK3352589 5mg/15mg/50mg - Subjects will receive single oral dose of placebo tablet in Period 1 followed by GSK3352589 5 milligrams (mg) tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A:Cohort 1:GSK3352589 2mg/ Placebo/GSK3352589 15mg/50mg - Subjects will receive single oral dose of GSK3352589 2 mg tablet in Period 1 followed by Placebo tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A:Cohort 1: GSK3352589 2mg/5mg/Placebo/GSK3352589 50mg - Subjects will receive single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by Placebo tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A:Cohort 1: GSK3352589 2mg/5mg/15mg/Placebo - Subjects will receive single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by Placebo tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A:Cohort 2: GSK3352589 25mg Fasted/GSK3352589 25mg Fed - Subjects will receive single oral dose of GSK3352589 25 mg tablet in Period 1 (fasted state) and Period 2 (fed state). Subjects will return for their next scheduled dosing Period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A: Cohort 2: Placebo Fasted/Placebo Fed - Subjects will receive single oral dose of placebo tablet matching GSK3352589 25 mg in Period 1 (fasted state) and Period 2 (fed state). Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A:Cohort 3: GSK3352589 150 mg/Placebo - Subjects will receive single oral dose of GSK3352589 150 mg tablet in Period 1 followed by placebo tablet matching GSK3352589 150 mg in Period 2 in Cohort 3 of Part A. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A:Cohort 3: Placebo/GSK3352589 400 mg - Subjects will receive single oral dose of placebo tablet matching GSK3352589 400 mg in Period 1 followed by single oral dose of GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part A:Cohort 3: GSK3352589 150mg/GSK3352589 400mg - Subjects will receive single oral dose of GSK3352589 150 mg tablet in Period 1 followed by GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
Experimental: Part B: GSK3352589 - Subjects will receive repeat oral doses of GSK3352589 of 5 mg, 15 mg, 50 mg, 100 mg or 200 mg twice daily administered for 14 days.
Placebo Comparator: Part B: Placebo - Subjects will receive repeat oral doses of placebo twice a day tablet administered for 14 days.
Treatment: Drugs: GSK3352589
It will be available in the dose of 1, 5, 25 and 100 mg tablet for oral administration.
Treatment: Drugs: Matching Placebo
It will be available across all strengths to match active drug in the form of tablet for oral administration.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs in Cohort 1
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
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Timepoint [1]
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Up to 64 days in Cohort 1
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Primary outcome [2]
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Part A: Number of Participants With SAEs and Non-SAEs in Cohort 2
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Assessment method [2]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
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Timepoint [2]
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Up to 30 days in Cohort 2
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Primary outcome [3]
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Part A: Number of Participants With SAEs and Non-SAEs in Cohort 3
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Assessment method [3]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
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Timepoint [3]
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0
Up to 30 days in Cohort 3
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Primary outcome [4]
0
0
Part B: Number of Participants With SAEs and Non-SAEs
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Assessment method [4]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
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Timepoint [4]
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Up to 25 days
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Primary outcome [5]
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Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 1
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Assessment method [5]
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A complete physical examination will include, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
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Timepoint [5]
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Up to 64 days in Cohort 1
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Primary outcome [6]
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Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 2
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Assessment method [6]
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A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
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Timepoint [6]
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Up to 30 days in Cohort 2
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Primary outcome [7]
0
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Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 3
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Assessment method [7]
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A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
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Timepoint [7]
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Up to 30 days in Cohort 3
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Primary outcome [8]
0
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Part B: Number of Participants With Abnormal Findings After Physical Examination
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Assessment method [8]
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A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
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Timepoint [8]
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Up to 25 days
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Primary outcome [9]
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Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
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Assessment method [9]
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Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) findings for ECG parameters have been presented.
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Timepoint [9]
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Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2
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Primary outcome [10]
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Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
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Assessment method [10]
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Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). The number of participants with abnormal CS and NCS findings for ECG parameters have been presented.
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Timepoint [10]
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0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2
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Primary outcome [11]
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Part B: Number of Participants With Abnormal ECG Findings
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Assessment method [11]
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0
Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug. The number of participants with abnormal CS and NCS findings for ECG parameters have been presented.
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Timepoint [11]
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0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 7 (Pre-dose, 4 Hours Post-dose), Day 14 (Pre-dose, 4 Hours Post-dose), Follow-up (Day 25)
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Primary outcome [12]
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Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
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Assessment method [12]
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Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [12]
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0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
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Primary outcome [13]
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Part A: Change From Baseline in SBP and DBP in Cohort 2
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Assessment method [13]
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Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [13]
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0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
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Primary outcome [14]
0
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Part B: Change From Baseline in SBP and DBP
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Assessment method [14]
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Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [14]
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0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)
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Primary outcome [15]
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0
Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3
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Assessment method [15]
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Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [15]
0
0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
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Primary outcome [16]
0
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Part A: Change From Baseline in Pulse Rate in Cohort 2
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Assessment method [16]
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Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [16]
0
0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
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Primary outcome [17]
0
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Part B: Change From Baseline in Pulse Rate
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Assessment method [17]
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Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [17]
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0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)
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Primary outcome [18]
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Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3
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Assessment method [18]
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Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [18]
0
0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
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Primary outcome [19]
0
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Part A: Change From Baseline in Body Temperature in Cohort 2
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Assessment method [19]
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0
Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [19]
0
0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
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Primary outcome [20]
0
0
Part B: Change From Baseline in Body Temperature
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Assessment method [20]
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0
Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [20]
0
0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)
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Primary outcome [21]
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0
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
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Assessment method [21]
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The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
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Timepoint [21]
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0
Up to 64 days in Cohort 1
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Primary outcome [22]
0
0
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
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Assessment method [22]
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0
The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
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Timepoint [22]
0
0
Up to 30 days in Cohort 2
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Primary outcome [23]
0
0
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
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Assessment method [23]
0
0
The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
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Timepoint [23]
0
0
Up to 30 days in Cohort 3
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Primary outcome [24]
0
0
Part B: Average BSFS at Indicated Time Points
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Assessment method [24]
0
0
The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
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Timepoint [24]
0
0
Day -1, Days 1-3, Days 4-7, Days 1-7, Days 8-14
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Primary outcome [25]
0
0
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
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Assessment method [25]
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0
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [25]
0
0
Baseline (Day -1) and Day 3
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Primary outcome [26]
0
0
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
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Assessment method [26]
0
0
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [26]
0
0
Baseline (Day -1) and Day 3
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Primary outcome [27]
0
0
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
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Assessment method [27]
0
0
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [27]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
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Primary outcome [28]
0
0
Part A: Change From Baseline in Erythrocytes in Cohort 1 and 3
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Assessment method [28]
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0
Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [28]
0
0
Baseline (Day -1) and Day 3
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Primary outcome [29]
0
0
Part A: Change From Baseline in Erythrocytes in Cohort 2
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Assessment method [29]
0
0
Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [29]
0
0
Baseline (Day -1) and Day 3
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Primary outcome [30]
0
0
Part B: Change From Baseline in Erythrocytes
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Assessment method [30]
0
0
Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [30]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
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Primary outcome [31]
0
0
Part A: Change From Baseline in Hemoglobin in Cohort 1 and 3
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Assessment method [31]
0
0
Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
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Timepoint [31]
0
0
Baseline (Day -1) and Day 3
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Primary outcome [32]
0
0
Part A: Change From Baseline in Hemoglobin in Cohort 2
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Assessment method [32]
0
0
Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [32]
0
0
Baseline (Day -1) and Day 3
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Primary outcome [33]
0
0
Part B: Change From Baseline in Hemoglobin
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Assessment method [33]
0
0
Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [33]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
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Primary outcome [34]
0
0
Part A: Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) in Cohort 1 and Cohort 3
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Assessment method [34]
0
0
Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [34]
0
0
Baseline (Day -1) and Day 3
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Primary outcome [35]
0
0
Part A: Change From Baseline in Erythrocyte MCV in Cohort 2
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Assessment method [35]
0
0
Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [35]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [36]
0
0
Part B: Change From Baseline in Erythrocyte MCV
Query!
Assessment method [36]
0
0
Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [36]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [37]
0
0
Part A: Change From Baseline in Erythorocyte Mean Corpuscular Hemoglobin (MCH) in Cohort 1 and 3
Query!
Assessment method [37]
0
0
Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [37]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [38]
0
0
Part A: Change From Baseline in Erythrocyte MCH in Cohort 2
Query!
Assessment method [38]
0
0
Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [38]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [39]
0
0
Part B: Change From Baseline in Erythrocyte MCH
Query!
Assessment method [39]
0
0
Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [39]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [40]
0
0
Part A: Change From Baseline in Hematocrit in Cohort 1 and 3
Query!
Assessment method [40]
0
0
Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [40]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [41]
0
0
Part A: Change From Baseline in Hematocrit in Cohort 2
Query!
Assessment method [41]
0
0
Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [41]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [42]
0
0
Part B: Change From Baseline in Hematocrit
Query!
Assessment method [42]
0
0
Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [42]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [43]
0
0
Part A: Change From Baseline in Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST), Alkaline Phosphatase (Alk Phos) in Cohort 1 and 3
Query!
Assessment method [43]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [43]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [44]
0
0
Part A: Change From Baseline in ALT, AST and Alk Phos in Cohort 2
Query!
Assessment method [44]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [44]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [45]
0
0
Part B: Change From Baseline in ALT, AST and Alk Phos
Query!
Assessment method [45]
0
0
Blood samples were collected for analysis of hematology parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [45]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [46]
0
0
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 1 and 3
Query!
Assessment method [46]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including bilirubin, creatinine, direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [46]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [47]
0
0
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 2
Query!
Assessment method [47]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including bilirubin, creatinine, and direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [47]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [48]
0
0
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Query!
Assessment method [48]
0
0
Blood samples were collected for analysis of hematology parameters including bilirubin, creatinine, and direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [48]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [49]
0
0
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3
Query!
Assessment method [49]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [49]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [50]
0
0
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2
Query!
Assessment method [50]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [50]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [51]
0
0
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Query!
Assessment method [51]
0
0
Blood samples were collected for analysis of hematology parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [51]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [52]
0
0
Part A: Change From Baseline in Albumin and Total Protein in Cohort 1 and 3
Query!
Assessment method [52]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including albumin, and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [52]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [53]
0
0
Part A: Change From Baseline in Albumin and Total Protein in Cohort 2
Query!
Assessment method [53]
0
0
Blood samples were collected for analysis of clinical chemistry parameters including albumin and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [53]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [54]
0
0
Part B: Change From Baseline in Albumin, Total Protein
Query!
Assessment method [54]
0
0
Blood samples were collected for analysis of hematology parameters including albumin and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [54]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [55]
0
0
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Query!
Assessment method [55]
0
0
Urine samples were collected from participants for analysis of specific gravity of urine. Urine parameters including bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, potential of hydrogen (pH), protein, specific gravity and Urobilinogen were analyzed by dipstick method. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period
1 (or the first available Dosing Period if Dosing Period 1 is unavailable).
Query!
Timepoint [55]
0
0
Baseline (Day-1) and Day 3
Query!
Primary outcome [56]
0
0
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Query!
Assessment method [56]
0
0
Urine samples were collected from participants for analysis of specific gravity of urine. Urine parameters including bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, potential of hydrogen (pH), protein, specific gravity and Urobilinogen were analyzed by dipstick method. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period
1 (or the first available Dosing Period if Dosing Period 1 is unavailable).
Query!
Timepoint [56]
0
0
Baseline (Day -1) and Day 3
Query!
Primary outcome [57]
0
0
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Query!
Assessment method [57]
0
0
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Query!
Timepoint [57]
0
0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Query!
Primary outcome [58]
0
0
Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Non-zero Concentration (AUC [0-t]) Following Single Dose Administration of GSK3352589
Query!
Assessment method [58]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods. The PK Parameter population comprised of all randomized participants who received at least one dose of active treatment and who had GSK3352589 Pharmacokinetic parameter estimates from any portion of the study.
Query!
Timepoint [58]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [59]
0
0
Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK3352589
Query!
Assessment method [59]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Query!
Timepoint [59]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [60]
0
0
Part A: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of GSK3352589
Query!
Assessment method [60]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including Cmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Query!
Timepoint [60]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [61]
0
0
Part A: Time to Reach Cmax (Tmax) Following Single Dose Administration of GSK3352589
Query!
Assessment method [61]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including Tmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Query!
Timepoint [61]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [62]
0
0
Part A: Terminal Elimination Half-life (t1/2) Following Single Dose Administration of GSK3352589
Query!
Assessment method [62]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including t1/2 following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Query!
Timepoint [62]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [63]
0
0
Part A: Cmax Following Single Dose Administration of GSK3352589-Food Effect
Query!
Assessment method [63]
0
0
Blood samples were collected from participants for pharmacokinetic analysis following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Query!
Timepoint [63]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [64]
0
0
Part A: AUC (0-t) Following Single Dose Administration of GSK3352589- Food Effect
Query!
Assessment method [64]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Query!
Timepoint [64]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [65]
0
0
Part A: AUC (0-infinity) Following Single Dose Administration of GSK3352589- Food Effect
Query!
Assessment method [65]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Query!
Timepoint [65]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Query!
Primary outcome [66]
0
0
Part B: AUC (0-t) Following Repeat Dose Administration of GSK3352589
Query!
Assessment method [66]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Query!
Timepoint [66]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Query!
Primary outcome [67]
0
0
Part B: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC [0-24]) Following Repeat Dose Administration of GSK3352589
Query!
Assessment method [67]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-24) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Query!
Timepoint [67]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Query!
Primary outcome [68]
0
0
Part B: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK3352589
Query!
Assessment method [68]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Query!
Timepoint [68]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Query!
Primary outcome [69]
0
0
Part B: Cmax Following Repeat Dose Administration of GSK3352589
Query!
Assessment method [69]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including Cmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Query!
Timepoint [69]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Query!
Primary outcome [70]
0
0
Part B: Tmax Following Repeat Dose Administration of GSK3352589
Query!
Assessment method [70]
0
0
Blood samples were collected from participants for pharmacokinetic analysis including Tmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Query!
Timepoint [70]
0
0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Query!
Eligibility
Key inclusion criteria
- Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator based on a medical evaluation including
medical history, physical examination, laboratory tests and cardiac monitoring. -
History of regular bowel habits
- Male or Female of non-childbearing potential.
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- ALT and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is
acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Previous Diagnosis of IBS
- Estimated Glomerular Filtration Rate <60 millilter per minute per 1.73 square meter
(mL/min/1.73m^2)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones)
- History of Gastroesophageal reflux disease (GERD), dyspepsia, Gastrointestinal (GI)
bleeding, diverticulitis, diverticular stricture or other intestinal strictures, GI
surgery that could affect motility
- Unwillingness or inability to follow the procedures outlined in the protocol
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/05/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
5/03/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
68
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of
escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a
randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that
will have two parts; Part A and Part B.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03154086
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03154086
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