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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03227471
Registration number
NCT03227471
Ethics application status
Date submitted
18/07/2017
Date registered
24/07/2017
Date last updated
18/01/2022
Titles & IDs
Public title
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
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Scientific title
A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
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Secondary ID [1]
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2017-000797-11
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Secondary ID [2]
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VX16-445-001
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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:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IVA
Treatment: Drugs - TEZ/IVA
Treatment: Drugs - VX-445
Treatment: Drugs - Matched Placebo
Treatment: Drugs - TEZ
Treatment: Drugs - VX-561
Treatment: Drugs - VX-445
Placebo comparator: Part A: Pooled Placebo (Except Cohort A7) - Participants without CF who received single dose of placebo matched to VX-445 in Cohort A1 to A5.
Experimental: Part A: VX-445 (Except Cohort A7) - Participants without CF who received single ascending dose of VX-445 tablet starting from 20 milligrams (mg) to 360 mg in Cohort A1 to A5.
Experimental: Part A: VX-445 (Cohort A7) - Participants without CF who received single dose of VX-445 100 mg tablet on Day 1 in fasted state and on Day 7 in fed state, followed by VX-445 20 mg intravenous (IV) injection on Day 13 in fed state in Cohort A7.
Placebo comparator: Part B: Pooled Placebo (Cohort B1 to B4) - Participants without CF who received multiple doses of placebo matched to VX-445 once daily (qd) for 10 days in Cohort B1 to B4.
Experimental: Part B: VX-445 (Cohort B1 to B4) - Participants without CF who received VX-445 tablet qd for 10 days in Cohort B1 (60 mg), B2 (120 mg), B3 (240 mg) and B4 (340 mg).
Placebo comparator: Part C: Pooled Placebo (Cohort C1 to C3) - Participants without CF who received placebo matched to VX-445/TEZ/IVA triple combination (TC) qd in the morning and placebo matched to IVA in the evening for 14 days.
Experimental: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3) - Participants without CF who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C1; VX-445 280 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C2 and VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in Cohort C3 for 14 days.
Placebo comparator: Part D: Placebo - Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/IVA TC qd in the morning and placebo matched to IVA qd in the evening for 4 weeks in the TC treatment period.
Experimental: Part D: VX-445/TEZ/IVA TC - Low Dose - Participants with CF, F/MF genotype who received VX-445 50 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
Experimental: Part D: VX-445/TEZ/IVA TC - Medium Dose - Participants with CF, F/MF genotype who received VX-445 100 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
Experimental: Part D: VX-445/TEZ/IVA TC - High Dose - Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the TC treatment period.
Active comparator: Part E: TEZ/IVA - Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received TEZ 100 mg qd/IVA 150 mg q12h and placebo matched to VX-445 for 4 weeks in the TC treatment period.
Experimental: Part E: VX-445/TEZ/IVA TC - Following run-in period of 4 weeks with TEZ/IVA, participants with CF, F/F genotype who received VX-445 200 mg qd/TEZ 100 mg qd /IVA 150 mg q12h for 4 weeks in the TC treatment period.
Placebo comparator: Part F: Placebo - Participants with CF, F/MF genotype who received placebo matched to VX-445/TEZ/VX-561 for 4 weeks in the TC treatment period.
Experimental: Part F: VX-445/TEZ/VX-561 TC - Participants with CF, F/MF genotype who received VX-445 200 mg qd/TEZ 100 mg qd/VX-561 150 mg qd for 4 weeks in the TC treatment period.
Treatment: Drugs: IVA
IVA tablet for oral administration
Treatment: Drugs: TEZ/IVA
TEZ/IVA fixed-dose combination for oral administration.
Treatment: Drugs: VX-445
VX-445 tablet for oral administration.
Treatment: Drugs: Matched Placebo
Matched placebo.
Treatment: Drugs: TEZ
Tablet for oral administration.
Treatment: Drugs: VX-561
Tablet for oral administration.
Treatment: Drugs: VX-445
VX-445 IV injection
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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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Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Timepoint [1]
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From first dose of study drug in treatment period up to safety follow-up (up to 28 days)
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Primary outcome [2]
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Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [2]
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Timepoint [2]
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From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)
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Primary outcome [3]
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Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [3]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
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Timepoint [3]
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From Baseline through Day 29
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Primary outcome [4]
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Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [4]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
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Timepoint [4]
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From Baseline through Day 29
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Primary outcome [5]
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Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [5]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
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Timepoint [5]
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From Baseline through Day 29
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Secondary outcome [1]
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Part A: Maximum Observed Concentration (Cmax) of VX-445
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Assessment method [1]
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Timepoint [1]
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Cohort A1-A5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
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Secondary outcome [2]
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Part A: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
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Assessment method [2]
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Timepoint [2]
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Cohort A1-5: Pre-dose to 96 hours post-dose; Cohort A7: Pre-dose to 120 hours post-dose
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Secondary outcome [3]
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Part B: Maximum Observed Concentration (Cmax) of VX-445
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Assessment method [3]
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Timepoint [3]
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Pre-dose to 96 hours post-dose on Day 1 and Day 10
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Secondary outcome [4]
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Part B: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445
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Assessment method [4]
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Timepoint [4]
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Pre-dose to 96 hours post-dose on Day 1 and Day 10
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Secondary outcome [5]
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Part B: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445
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Assessment method [5]
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Timepoint [5]
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Pre-dose on Day 10
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Secondary outcome [6]
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Part C: Maximum Observed Concentration (Cmax) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
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Assessment method [6]
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Timepoint [6]
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Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
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Secondary outcome [7]
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Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
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Assessment method [7]
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Timepoint [7]
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Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
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Secondary outcome [8]
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Part C: Maximum Observed Concentration (Cmax) of IVA and Its Metabolites (M1-IVA and M6-IVA)
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Assessment method [8]
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Timepoint [8]
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Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
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Secondary outcome [9]
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Part C: Area Under Plasma Concentration Time Curve From Time of Dosing to Last Measurable Concentration (AUC0-tlast) of IVA and Its Metabolites (M1-IVA and M6-IVA)
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Assessment method [9]
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Timepoint [9]
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Pre-dose to 96 hours post-dose on Day 1, Day 7 and Day 14
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Secondary outcome [10]
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Part C: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolites (M1-TEZ and M2-TEZ)
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Assessment method [10]
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0
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Timepoint [10]
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Pre-dose on Day 7 and Day 14
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Secondary outcome [11]
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Part C: Observed Pre-dose Concentration (Ctrough) of IVA and Its Metabolites (M1-IVA and M6-IVA)
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Assessment method [11]
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Timepoint [11]
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Pre-dose on Day 7 and Day 14
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Secondary outcome [12]
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Part D: Observed Pre-dose Plasma Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ), IVA and Its Metabolite (M1-IVA)
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Assessment method [12]
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0
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Timepoint [12]
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Pre-dose on Day 15 and Day 29
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Secondary outcome [13]
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Part E: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and IVA and Its Metabolite (M1-IVA)
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Assessment method [13]
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Timepoint [13]
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Pre-dose on Day 15 and Day 29
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Secondary outcome [14]
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Part F: Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ and Its Metabolite (M1-TEZ) and VX-561
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Assessment method [14]
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Timepoint [14]
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Pre-dose on Day 15 and Day 29
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Secondary outcome [15]
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Part D: Absolute Change in Sweat Chloride Concentration
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Assessment method [15]
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Sweat samples were collected using an approved collection device.
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Timepoint [15]
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From Baseline through Day 29
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Secondary outcome [16]
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Part E: Absolute Change in Sweat Chloride Concentration
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Assessment method [16]
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Sweat samples were collected using an approved collection device.
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Timepoint [16]
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From Baseline through Day 29
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Secondary outcome [17]
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Part F: Absolute Change in Sweat Chloride Concentration
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Assessment method [17]
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Sweat samples were collected using an approved collection device.
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Timepoint [17]
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From Baseline through Day 29
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Secondary outcome [18]
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Part D: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [18]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
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Timepoint [18]
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From Baseline through Day 29
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Secondary outcome [19]
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Part E: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [19]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
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Timepoint [19]
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From Baseline through Day 29
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Secondary outcome [20]
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Part F: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
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Assessment method [20]
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
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Timepoint [20]
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From Baseline through Day 29
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Secondary outcome [21]
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Part D: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
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Assessment method [21]
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The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
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Timepoint [21]
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From Baseline through Day 29
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Secondary outcome [22]
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Part E: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
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Assessment method [22]
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The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
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Timepoint [22]
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From Baseline through Day 29
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Secondary outcome [23]
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Part F: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
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Assessment method [23]
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The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
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Timepoint [23]
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From Baseline through Day 29
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Eligibility
Key inclusion criteria
Key
Parts A, B, and C:
* Female subjects must be of non-childbearing potential.
* Between the ages of 18 and 55 years, inclusive.
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg
Parts D, E, and F:
* Body weight =35 kg.
* Subjects must have an eligible CFTR genotype:
* Parts D and F: Heterozygous for F508del and an MF mutation (F/MF)
* Part E: Homozygous for F508del (F/F)
* FEV1 value =40% and =90% of predicted mean for age, sex, and height.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Parts A, B, and C:
* Any condition possibly affecting drug absorption.
* History of febrile illness within 14 days before the first study drug dose.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Parts D, E, and F:
* History of clinically significant cirrhosis with or without portal hypertension.
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* Lung infection with organisms associated with a more rapid decline in pulmonary status.
* History of solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/03/2018
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Sample size
Target
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Accrual to date
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Final
225
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Center - Clayton
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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The Royal Children's Hospital Melbourne - Parkville
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Recruitment hospital [4]
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Mater Adult Hospital - Brisbane
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Royal Prince Alfred Hospital - Sydney
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
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- Clayton
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- Melbourne
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- Parkville
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- Brisbane
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- Sydney
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Louisiana
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Michigan
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Minnesota
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New Jersey
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New Mexico
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Ohio
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Texas
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Vermont
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Virginia
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Wisconsin
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Belgium
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Edegem
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Belgium
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Gent
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Netherlands
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Amsterdam
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Netherlands
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Den Haag
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Netherlands
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Nijmegen
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Netherlands
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State/province [25]
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Rotterdam
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Vertex Pharmaceuticals Incorporated
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
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Trial website
https://clinicaltrials.gov/study/NCT03227471
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Trial related presentations / publications
Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3. Keating D, Marigowda G, Burr L, Daines C, Mall MA, McKone EF, Ramsey BW, Rowe SM, Sass LA, Tullis E, McKee CM, Moskowitz SM, Robertson S, Savage J, Simard C, Van Goor F, Waltz D, Xuan F, Young T, Taylor-Cousar JL; VX16-445-001 Study Group. VX-445-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles. N Engl J Med. 2018 Oct 25;379(17):1612-1620. doi: 10.1056/NEJMoa1807120. Epub 2018 Oct 18.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/71/NCT03227471/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/71/NCT03227471/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03227471
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