Malaria Clinical Trial
Official title:
A Phase I Study to Investigate the Hemolytic Potential of Tafenoquine in Healthy Subjects With Glucose-6-phosphate Dehydrogenase Deficiency and the Safety and Tolerability of Tafenoquine in Acute Plasmodium Vivax Malaria Patients With Glucose-6-phosphate Dehydrogenase Deficiency
SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed
by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and
Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of
acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3
days.
The current gold standard for radical cure of P. vivax malaria in many areas of the world is
chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine
(PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class
of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase
(G6PD) deficiency. The current study will identify a dose of TQ within the target
efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14
days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).
n/a
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