Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03258762 | Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects | PHASE1 | COMPLETED | 14 | — | — | Sep 25, 2017 | Nov 19, 2017 | Mar 27, 2020 | 1 | Australia |
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.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Healthy Japanese male subjects | EXPERIMENTAL | 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. |
| Healthy Caucasian male subjects | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Pyrimethamine | DRUG | 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. |
| Calcium folinate | DRUG | 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. |
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 wei...