Overview

Pharmacokinetic and Mosquito-Lethal Effects of Ivermectin (IVM), Primaquine (PQ), Dihydroartemisinin-Piperaquine (DHA-PQP) and Albendazole (ABZ) in Healthy Subjects

Status:
Completed

Trial end date:
2016-12-01

Target enrollment:

Participant gender:

Summary

Primary Objective - To evaluate the safety and tolerability of co-administered single dose Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and Albendazole (ABZ) in healthy subjects. Secondary Objectives - To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ, and ABZ in healthy adult subjects. - To characterize the pharmacokinetic properties of PQ (and its major metabolite), DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination. - To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM, ABZ and their metabolites. - To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against Anopheles dirus and Anopheles minimus. - To determine if IVM concentrations in venous blood differs from capillary blood.

Phase:

Phase 1

Details

Lead Sponsor:

University of Oxford

Collaborators:

Mahidol Oxford Tropical Medicine Research Unit
Mahidol University

Treatments:

Albendazole
Artemisinins
Dihydroartemisinin
Ivermectin
Piperaquine
Primaquine