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COMPLETED
NCT03320174
PHASE2

Long-Term Safety Study of Tafenoquine

Sponsor: 60 Degrees Pharmaceuticals LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

Tafenoquine

Tafenoquine 200mg

OTHER

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