Pharmacokinetic and Mosquito-Lethal Effects of Ivermectin (IVM), Primaquine (PQ), Dihydroartemisinin-Piperaquine (DHA-PQP) and Albendazole (ABZ) in Healthy Subjects
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.
Timeline
- Start
- 2015-10
- Primary completion
- 2016-12
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 40 mg | Oral |
| Subject | Ivermectin | Small molecule | 400 ug/kg | Oral |
| Subject | Primaquine | Small molecule | 15 mg | Oral |
| Subject | piperaquine | Small molecule | 320 mg | Oral |
Indications
No indication recorded.