Open-label study to evaluate safety, tolerability, potential pharmacokinetic interactions and mosquito-lethal effects of orally administered ivermectin, primaquine, dihydroartemisinin-piperaquine, and albendazole in healthy adult subjects

Open-label study to evaluate safety, tolerability, potential pharmacokinetic interactions and mosquito-lethal effects of orally administered ivermectin, primaquine, dihydroartemisinin-piperaquine, and albendazole in healthy adult subjects

Objectives

The primary objective of this project is to evaluate the safety and tolerability of co-administered single dose dihydroartemisinin-piperaquine (DHA-PPQ), ivermectin (IVM), primaquine (PQ), and albendazole (ABZ) in healthy subjects.

The secondary objectives are:

  • To characterize the potential pharmacokinetic interactions between DHA-PPQ, IVM, PQ, and ABZ in healthy adult subjects.
  • To characterize the pharmacokinetic properties of PQ (and its major metabolite), DHA-PPQ, IVM, and ABZ (and its major metabolite) when given alone and in combination.
  • To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PPQ, IVM, ABZ and their metabolites.
  • To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PPQ combinations against Anopheles dirus and Anopheles minimus.
  • To determine if IVM concentrations in venous blood differs from capillary blood.

PI Institution(s)

Principal Investigator (PI)

Funding source(s)

Partner(s)

Abstract

Brief title: Pharmacokinetic and mosquito-lethal effects of ivermectin (IVM), primaquine (PQ), dihydroartemisinin-piperaquine (DHA-PPQ) and albendazole (ABZ) in healthy subjects. Ivermectin for Malaria in Southeast Asia (IMSEA)

Currently, in the Greater Mekong Subregion, mass drug administrations (MDAs) with dihydroartemisinin-piperaquine and primaquine are being conducted with the goal of local elimination of all falciparum malaria parasites. Ivermectin MDAs in West Africa reduced Anopheles gambiae survivorship and the proportion of P. falciparum-infectious An. gambiae. Preliminary lab studies illustrated that important GMS malaria vectors are susceptible to ivermectin. Thus ivermectin could be incorporated in MDAs with dihydroartemisinin-piperaquine and primaquine. However, before large-scale deployment in MDAs, the safety and tolerability of these drugs must be evaluated. This clinical trial is a sequential trial in healthy Thai adult volunteers to assess the safety, tolerability, pharmacokinetic interaction, and mosquito-lethal efficacy of ivermectin, dihydroartemisinin-piperaquine, and primaquine.  

*Check what the researchers shared about this project at ASTMH 2016 in the Knowledge Hub (here and here).

Pharmacokinetic and Mosquito-Lethal Effects of Ivermectin (IVM), Primaquine (PQ), Dihydroartemisinin-Piperaquine (DHA-PQP) and A

Key facts

  • Dates
    Apr 2015 to Mar 2018
    Funding amount
    $219,083
    Funding information
    148,000 GBP
    Country
    • Thailand

MESA tags

  • Methodology
    Basic science, Entomology
    Theme(s)
    Drug-based strategies, Measurement of transmission, Tools for elimination