Long-Term Safety Study of Tafenoquine

Summary

This randomized, double-blind, placebo controlled study will involve 600 healthy (Glucose-6-Phosphate Dehydrogenase \[G6PD\] normal) volunteers. Participants who meet the eligibility criteria will be randomized (ratio 1:1) to receive a loading dose of either tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit will continue to be assessed for up to 3 more times at approximately 12-week intervals or until resolution or stabilization of the AE whichever is earlier.

Timeline

Start

2017-10-05

Primary completion

2021-07-13

Completion

2021-07-13

Publications

• Novitt-Moreno A, Martidis A, Gonzalez V, Ransom J, Scott CB, Dow G, Reid M, Smith B, Zottig VE, Read LT, Garver Baldwin LS, Chen FK. Long-term safety of the tafenoquine antimalarial chemoprophylaxis regimen: A 12-month, randomized, double-blind, placebo-controlled trial. Travel Med Infect Dis. 2022 Jan-Feb;45:102211. doi: 10.1016/j.tmaid.2021.102211. Epub 2021 Nov 18.

Drugs

Indications

No indication recorded.