At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine
In Brief
A Phase 2 clinical trial evaluating Tafenoquine and Placebo for Healthy Volunteers. Completed, enrolled 600 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Tafenoquine 200mg
Placebo