A Study to Assess the Availability of Oral Primaquine and Its Inert Metabolite, Carboxyprimaquine, in the Body
Status:
Withdrawn
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
An open-label pharmacokinetic study. This study will enroll 20 healthy adult subjects (10
males and 10 females aged 18-60 years) at the Clinical Therapeutics Unit or inpatient ward,
Faculty of Tropical Medicine, Mahidol University, Thailand.
The investigator propose to conduct a definitive bioavailability and pharmacokinetic study in
healthy adult volunteers, both male and female, with normal CYP2D6 genotypes to assess oral
primaquine bioavailability by the administration of intravenous and oral primaquine on
different days and calculate the proportion of drug converted to its inactive metabolite,
carboxyprimaquine, in order to estimate the proportion of its active metabolites. The
intravenous injection of the known amount of carboxyprimaquine will allow the calculation of
carboxyprimaquine's volume of distribution.
Phase:
Phase 1
Details
Lead Sponsor:
University of Oxford
Collaborators:
Faculty of Tropical Medicine, Mahidol University Bangkok, Thailand Mahidol Oxford Tropical Medicine Research Unit