Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali

Summary

The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which: * Two or fewer participants (\< 30%) experience hemolysis; * No participant experiences a drug-related serious adverse event; and * No participant requires a blood transfusion.

Timeline

Start

2015-08

Primary completion

2016-01

Completion

2016-01

Publications

• Chotsiri P, Mahamar A, Diawara H, Fasinu PS, Diarra K, Sanogo K, Bousema T, Walker LA, Brown JM, Dicko A, Gosling R, Chen I, Tarning J. Population pharmacokinetics of primaquine and its metabolites in African males. Malar J. 2024 May 21;23(1):159. doi: 10.1186/s12936-024-04979-y.
• Chen I, Diawara H, Mahamar A, Sanogo K, Keita S, Kone D, Diarra K, Djimde M, Keita M, Brown J, Roh ME, Hwang J, Pett H, Murphy M, Niemi M, Greenhouse B, Bousema T, Gosling R, Dicko A. Safety of Single-Dose Primaquine in G6PD-Deficient and G6PD-Normal Males in Mali Without Malaria: An Open-Label, Phase 1, Dose-Adjustment Trial. J Infect Dis. 2018 Mar 28;217(8):1298-1308. doi: 10.1093/infdis/jiy014.

Drugs

Indications