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Long-Term Safety Study of Tafenoquine
Sponsor: 60 Degrees Pharmaceuticals LLC
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.
Official title: Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2017-10-05
Completion Date
2021-07-13
Last Updated
2026-04-17
Healthy Volunteers
Yes
Conditions
Interventions
Tafenoquine
Tafenoquine 200mg
Placebo
Placebo
Locations (3)
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
Valley Retina Institute
McAllen, Texas, United States
Linear Clinical Research
Nedlands, Western Australia, Australia