Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects
Status:
Completed
Trial end date:
2017-11-19
Target enrollment:
Participant gender:
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.