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Clinical Trial 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.


Clinical Trial Description

This is an open-label, sequential pharmacokinetic study in 16 healthy glucose-6-phosphate dehydrogenase (G6PD) normal Thai subjects. These 16 subjects have previously participated in either study:

1. Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered Primaquine (PQ) and Dihydroartemisinin-Piperaquine (DHA-PQP) in Healthy Adult Subjects (TMEC 12-004 (OxTREC ref. 58-11)) or study

2. Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine (CQ) and piperaquine (PQ) in healthy Thai subjects (TMEC 14-022 (OxTREC ref. 39-14)) or

3. subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)".

The study team will use the results of DHA-PQP regimen of the subjects from the above mentioned studies to compare with combination regimens in this study. This is to avoid unnecessary exposure of Subjects from (TMEC 12-004 (OxTREC ref. 58-11)) and (TMEC 14-022 (OxTREC ref. 39-14)) to the subjects. In addition, subjects have previously been tested for G6PD deficiency during screening process from the above mentioned study with result showed as normal. Therefore, a G6PD deficiency test is not needed. A G6PD deficiency test is needed for subjects who not previously participated in study subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)" for this study.

Subjects will be admitted in the inpatient ward to receive single dose of 6 regimens (regimens 1-4 and 8-9) described below. Every subject will have at least 6 admissions in the hospital.

1: IVM (400 μg/kg) via 6 mg tabs, w-o** >4wks; 2: IVM (400 μg/kg)+PQ (15 mg): 2 tabs), w-o >4wks; 3: IVM (400 μg/kg)+DHA-PQP (40mg/320 mg): 3 tabs), w-o >8wks; 4: IVM (400 μg/kg)+DHA-PQP+PQ, w-o >8wks; 5*#: PQ (15 mg): 2 tabs, w-o > 2wks; 6#: DHA-PQP (40mg/320 mg): 3 tabs, w-o >8wks; 7*#: DHA-PQP (40mg/320 mg): 3 tabs +PQ (15 mg): 2 tabs, w-o >8wks; 8: ABZ (200 mg) 2 tabs, w-o >2wks; 9: IVM (400 μg/kg)+DHA-PQP (40mg/320 mg): 3 tabs+PQ (15 mg): 2 tabs +ABZ (400 mg): 1 tab, w-o >8wks

* The subjects from TMEC-14-022 (OxTREC ref. 39-14) will have two additional admissions to receive two additional regimen PQ, and DHA-PQP with PQ

# Subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)" will have three additional admissions to receive three additional regimens PQ, DHA-PQP, and DHA-PQP with PQ.

**w-o = washout period ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02568098
Study type Interventional
Source University of Oxford
Contact
Status Completed
Phase Phase 1
Start date October 2015
Completion date December 2016

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