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Long-Term Safety Study of Tafenoquine
NCT03320174 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- OTHER Placebo
- DRUG Tafenoquine
Study Locations (3)
Colorado
- Retina Consultants of Southern Colorado — Colorado Springs
Texas
- Valley Retina Institute — McAllen
Western Australia
- Linear Clinical Research — Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2017-10-05 |
| Est. Completion | 2021-07-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03320174
The ClinicalTrials.gov registry entry for NCT03320174 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is 60 Degrees Pharmaceuticals, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03320174 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Texas, Western Australia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03320174 about?
NCT03320174 is a clinical study titled "Long-Term Safety Study of Tafenoquine". 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) o...
What is the current status of trial NCT03320174?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2017-10-05. Estimated completion is 2021-07-13.
What conditions does trial NCT03320174 study?
This clinical trial studies the following conditions: Healthy Volunteers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03320174?
The interventions under investigation include: Placebo (OTHER), Tafenoquine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03320174?
This trial is sponsored by 60 Degrees Pharmaceuticals, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03320174 being conducted?
This trial has 3 study locations across Colorado, Texas, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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