Healthy Clinical Trial
Official title:
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
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.
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
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