Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pyrimethamine · 1 trial · 1 indication
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...
Pyrimethamine is a small molecule drug being developed by GSK plc for the treatment of toxoplasmosis, an infectious disease. It is currently in Phase 1 clinical development and is being studied in healthy volunteers to assess its safety and pharmacokinetics.
Pyrimethamine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for the treatment of toxoplasmosis.
Pyrimethamine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed to evaluate the drug in healthy subjects.
Pyrimethamine has one completed clinical trial, NCT03258762, a Phase 1 study conducted in Australia. The trial enrolled 14 healthy male subjects aged 20 years and older, including Japanese and Caucasian participants, to evaluate the drug's safety and pharmacokinetics.
Pyrimethamine is not FDA approved for the treatment of toxoplasmosis. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT03258762, was a Phase 1 study in healthy volunteers, and the drug has not yet progressed to later-stage trials.