Vivax Malaria Clinical Trial
Official title:
Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered Primaquine and Chloroquine in Healthy Thai Adult Subjects
This is a standard pharmacokinetic interaction study. Subjects will be randomized to be
either group A or B. Group A. Subjects will have 3 hospitalizations to complete. Each
hospitalization will be about 12-24 hours depends on each regimen. Subjects in A group who
receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2
of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1
week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third
admission (visit 4) after 8 weeks wash out period.
Subjects in B group who receive regimen 1 of primaquine (PQ) will receive regimen 2 of
chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of
primaquine and chloroquine combination (PQ and CQ)on third admission(visit 4) with 8 week
wash out period in between.
Chloroquine and primaquine, has been first therapy for Plasmodium vivax and ovale malaria
for over 50 years, and has been part of National policy in Thailand for decades. Primaquine
is the only available hypnozoitocidal drug for P.vivax and gametocytocidal agent for
Plasmodium falciparum malaria. Despite this enormous use knowledge about the mechanism of
activity, pharmacokinetic properties, resistance and toxicity of primaquine are limited.
Primaquine at the previously used dose for radical cure (15 mg base/day for 14 days) is also
weakly effective against asexual stages of P. vivax malaria [4] The higher dose of 30 mg
daily evaluated for malaria prophylaxis is now also generally recommended for radical cure.
In the standard radical cure regimen, primaquine is usually given after the 3-day course of
chloroquine, but there has been no study to inform timing of dosing so this decision is
arbitrary. Despite the multistage specificity against the malaria parasite, and extensive
recommendations, primaquine is currently underused because of uncertainties over safety,
efficacy and dosage. Primaquine is an oxidant drug and causes haemolysis in patients with
glucose-6-phosphate dehydrogenase deficiency (G6PD). Although several studies of the
metabolites of the primaquine and chloroquine have been conducted over the past few years
remarkably little is known about the interaction between these two commonly coadministered
drugs.
This study is open-label pharmacokinetic study. Healthy 16 volunteers will be recruited to
the established volunteer facility at single site at the Hospital for Tropical Diseases to
determine the pharmacokinetic properties of primaquine and it's main active metabolites and
evaluate any interaction with chloroquine.in order to provide clinical guidance for the
optimum primaquine/chloroquine treatment regimens.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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