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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/NCT03258762
Registration number
NCT03258762
Ethics application status
Date submitted
21/08/2017
Date registered
23/08/2017
Date last updated
27/03/2020
Titles & IDs
Public title
Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects
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Scientific title
A Single Centre, Open-label, Parallel-group, Single Oral Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pyrimethamine in Healthy Japanese and Caucasian Male Subjects
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Secondary ID [1]
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204678
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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:
Toxoplasmosis
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pyrimethamine
Treatment: Drugs - Calcium folinate
Experimental: Healthy Japanese male subjects - Healthy Japanese male subjects will receive a single oral dose of Pyrimethamine 50 mg in the fasted state co-administered with calcium folinate 15 mg on Day 1. Oral calcium folinate will be administered once daily until Day 8. Blood samples for PK analysis will be collected prior to administering first dose of Pyrimethamine and over 22 days post dose. Each subject will participate in the study for a duration of approximately 2 months from screening to follow-up.
Experimental: Healthy Caucasian male subjects - Healthy Caucasian male subjects will receive a single oral dose of Pyrimethamine 50 mg in the fasted state co-administered with calcium folinate 15 mg on Day 1. Oral calcium folinate will be administered once daily until Day 8. Blood samples for PK analysis will be collected prior to administering first dose of Pyrimethamine and over 22 days post dose. Each subject will participate in the study for a duration of approximately 2 months from screening to follow-up.
Treatment: Drugs: Pyrimethamine
Pyrimethamine will be available as 25 mg tablets. Subjects will be orally administered two pyrimethamine tablets on Day 1 in a fasted condition with 240 mL of water.
Treatment: Drugs: Calcium folinate
Calcium folinate will be available as 5 mg tablets. Subjects will be orally administered three calcium folinate tablets on Day 1 along with pyrimethamine followed by once daily administration of calcium folinate until Day 8. Each administration will be with 240 mL water.
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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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Maximum Observed Concentration (Cmax) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [1]
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Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. PK Population is defined as all participants who administered at least one dose of study treatment and who have PK sample taken and analyzed.
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Timepoint [1]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Primary outcome [2]
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Area Under the Concentration-time Curve From Time 0 to t (AUC[0-t]) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [2]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [2]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Primary outcome [3]
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Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [3]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [3]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Primary outcome [4]
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Area Under the Concentration-time Curve From Time 0 to 24 (AUC[0-24]) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [4]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [4]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Primary outcome [5]
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Terminal Half-life (t1/2) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [5]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [5]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Primary outcome [6]
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Time to Maximum Observed Concentration (Tmax) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [6]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [6]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Primary outcome [7]
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Apparent Clearance Following Oral Dosing (CL/F) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [7]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [7]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Primary outcome [8]
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Apparent Volume of Distribution Following Oral Dosing (Vd/F) of Pyrimethamine in Healthy Japanese Male Participants
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Assessment method [8]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [8]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [1]
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Cmax of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [1]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [1]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [2]
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AUC (0-t) of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [2]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [2]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [3]
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AUC (0-inf) of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [3]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [3]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [4]
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AUC (0-24) of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [4]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [4]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [5]
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Tmax of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [5]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [5]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [6]
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T1/2 of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [6]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [6]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [7]
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CL/F of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [7]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [7]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [8]
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Vd/F of Pyrimethamine in Healthy Caucasian Male Participants
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Assessment method [8]
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Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
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Timepoint [8]
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Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22
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Secondary outcome [9]
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Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
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Assessment method [9]
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An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants who take at least one dose of study treatment were included in Safety Population.
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Timepoint [9]
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Up to Day 23
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Secondary outcome [10]
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Change From Baseline of Clinical Chemistry Parameters: Glucose, Sodium, Calcium, Potassium, and Urea.
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Assessment method [10]
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Blood samples were collected for the analysis of clinical chemistry parameters including glucose, sodium, calcium, potassium, and urea at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [10]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [11]
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Change From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
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Assessment method [11]
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Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphatase, ALT and AST at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [11]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [12]
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Change From Baseline of Clinical Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine.
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Assessment method [12]
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Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, bilirubin and creatinine at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [12]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [13]
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Change From Baseline of Clinical Chemistry Parameters: Protein
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Assessment method [13]
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Blood samples were collected for the analysis of clinical chemistry parameter including protein at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [13]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [14]
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Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and Leukocytes
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Assessment method [14]
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Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. Data was not available as all basophil values were below the detection limit. Hence, the change from baseline in basophil values were not calculated.
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Timepoint [14]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [15]
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Change From Baseline in Hematology Parameter: Reticulocytes
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Assessment method [15]
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Blood samples were collected for the analysis of hematology parameter including reticulocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [15]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [16]
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Change From Baseline in Hematology Parameter: Hematocrit
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Assessment method [16]
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Blood samples were collected for the analysis of hematology parameter including hematocrit at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [16]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [17]
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Change From Baseline in Hematology Parameter: Hemoglobin
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Assessment method [17]
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Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [17]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [18]
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Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
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Assessment method [18]
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Blood samples were collected for the analysis of hematology parameter including mean corpuscular hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [18]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [19]
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Change From Baseline in Hematology Parameter: Mean Corpuscular Volume
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Assessment method [19]
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Blood samples were collected for the analysis of hematology parameter including mean corpuscular volume at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [19]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [20]
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Change From Baseline in Hematology Parameter: Erythrocytes
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Assessment method [20]
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Blood samples were collected for the analysis of hematology parameter including erythrocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [20]
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Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [21]
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Number of Participants With Abnormal Urinalysis Parameter
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Assessment method [21]
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The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of can be read as Trace, + and ++ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
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Timepoint [21]
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Day -1, 24, 96, 168, 336 and follow up (504 hours)
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Secondary outcome [22]
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Specific Gravity at Indicated Time Points
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Assessment method [22]
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Urine samples were collected for analysis of specific gravity of urine. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.
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Timepoint [22]
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Day -1, 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [23]
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Urine Potential of Hydrogen (pH) at Indicated Time Points
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Assessment method [23]
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Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
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Timepoint [23]
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Day -1, 24, 96, 168, 336 hours and follow up (504 hours)
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Secondary outcome [24]
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Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
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Assessment method [24]
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Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [24]
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Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours
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Secondary outcome [25]
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Change From Baseline in Pulse Rate
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Assessment method [25]
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Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [25]
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Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours
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Secondary outcome [26]
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Change From Baseline in Temperature
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Assessment method [26]
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Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [26]
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Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours
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Secondary outcome [27]
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Change From Baseline of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, and QT Interval Corrected for Heart Rate by Fredericia's Formula (QTcF) Interval
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Assessment method [27]
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A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically measures PR, QRS, QT, and QTcF intervals. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [27]
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Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours
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Secondary outcome [28]
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Change From Baseline of ECG Parameter: ECG Mean Heart Rate
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Assessment method [28]
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A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically calculates mean ECG heart rate. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.
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Timepoint [28]
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Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours
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Eligibility
Key inclusion criteria
- Subjects should be between 20 and 64 years of age inclusive, at the time of signing
the informed consent.
- Subjects who are overtly healthy as determined by medical evaluation including medical
history, physical examination, laboratory tests and cardiac monitoring.
- Body weight >= 50 kilograms (kg) and body mass index (BMI) within the range 18.5 to
30.0 kilogram per square meters (kg/m^2) (inclusive).
- Japanese or Caucasian male.
- A male subject must agree to use contraception during the treatment period and until
follow-up.
- Japanese ethnic origin defined as having been born in Japan, having four ethnic
Japanese grandparents, holding a Japanese passport or identity papers and being able
to speak Japanese. Subjects should also have lived outside Japan for less than 10
years at the time of screening.
- Caucasian subject will be defined as an individual having four grandparents who are
all descendants of the original people of Europe.
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions of the study.
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Minimum age
20
Years
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Maximum age
64
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Alanine aminotransferase (ALT) > 1.5 times upper limit of normal (ULN).
- Bilirubin > 1.5 times ULN (isolated bilirubin > 1.5 times ULN is acceptable if
bilirubin is fractionated and direct bilirubin < 35 percent).
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450
milliseconds (msec).
- 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 cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
hematological, or neurological disorders capable of significantly altering the
absorption, metabolism, or elimination of drugs; constituting a risk when taking the
study treatment; or interfering with the interpretation of data.
- Abnormal blood pressure as determined by the investigator.
- Hematological values: outside normal range at screening.
- Serum creatinine level: outside normal range at screening visit.
- Past or intended use of over-the-counter or prescription medication including herbal
medications within 14 days prior to dosing.
- Participation in the study would result in loss of blood or blood products in excess
of 500 milliliters (mL) within 3 months.
- Exposure to more than 4 new chemical entities within 12 months prior to the first
dosing day.
- Current enrollment or past participation within the last 30 days before signing of
consent in this clinical study involving an investigational study treatment or any
other type of medical research.
- Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C
antibody test result at screening. Subjects with positive Hepatitis C antibody due to
prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C
RNA test is obtained.
- Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3
months prior to first dose of study treatment. Test is optional and subjects with
negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA
testing.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular use of known drugs of abuse.
- Regular alcohol consumption within 6 months prior to the study defined as: For an
average weekly intake of > 14 units for males. One unit is equivalent to 10 grams (g)
of alcohol: a can of mid-strength (equivalent to 375 mL) beer, 1 glass (100 mL) of
table wine or 1 measure (30 mL) of spirits (including rice wine).
- History or regular use of tobacco- or nicotine-containing products within 6 months
prior to screening.
- Sensitivity to any of the study treatments, or components thereof, or drug or other
allergy that, in the opinion of the investigator or medical monitor, contraindicates
participation in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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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
25/09/2017
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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
19/11/2017
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Sample size
Target
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Accrual to date
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Final
14
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Pyrimethamine in combination with a sulphonamide is known to be effective in the treatment of
toxoplasmosis. However, Pyrimethamine has not been approved by the Japanese regulatory body
(Pharmaceutical and Medical Devices Agency [PMDA]/ Ministry of Health, Labor and Welfare
[MHLW]). The pharmacokinetics (PK) of Pyrimethamine has been investigated following
administration of Sulfadoxine/Pyrimethamine tablet in healthy Japanese subjects. However, the
study did not provide sufficient information for approval of Pyrimethamine in Japan; hence,
PMDA has requested confirmation of the PK of Pyrimethamine in another PK study in Japanese
and Caucasian healthy subjects. This study will be a single centre, open-label,
parallel-group, single oral dose study to evaluate the PK, safety and tolerability of
Pyrimethamine in healthy Japanese and Caucasian male subjects. Subjects will undergo a
screening visit within 30 days prior to first dose of the study drug. On Day 1, subjects will
be administered a single oral dose of pyrimethamine 50 milligrams (mg) along with calcium
folinate 15 mg after an overnight fast of at least 10 hours. Subjects will continue to
receive calcium folinate once daily until Day 8 of the treatment period. Blood sampling for
PK analysis and safety assessments will be performed prior to dosing and over 22 days after
dosing. Each subject will participate in the study for approximately 2 months from screening
to follow-up.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03258762
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Trial related presentations / publications
Iida T, Nand RA, Ino H, Ogura H, Itoh H, Igarashi H, Numachi Y, Gross AS. Evaluation of the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Pyrimethamine in Healthy Male Subjects of Japanese and European Ancestry. Clin Pharmacol Drug Dev. 2020 Aug;9(6):768-773. doi: 10.1002/cpdd.771. Epub 2020 Jan 16.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03258762
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