NCT03320174

Long-Term Safety Study of Tafenoquine

Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: 60 Degrees Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tafenoquine	Tafenoquine 200mg
OTHER	Placebo	Placebo

Timeline

• Start date: 2017-10-05
• Primary completion: 2021-07-13
• Completion: 2021-07-13
• First posted: 2017-10-25
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

3 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study