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NCT03320174 · ClinicalTrials.gov registry record · Phase 2
Long-Term Safety Study of Tafenoquine
A Phase 2 study of Healthy Volunteers, sponsored by 60 Degrees Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
- 3
- Study locations
NCT03320174 is a Phase 2 study of Healthy Volunteers that has completed, run by 60 Degrees Pharmaceuticals. The registered enrollment target is 600 participants, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (25% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT03320174, a Phase 2 study of Healthy Volunteers, has completed, sponsored by 60 Degrees Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
- 3
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (25% higher). The listed sponsor is 60 Degrees Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT03320174 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, Texas, Western Australia.
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.
What interventions are being tested in trial NCT03320174?
The interventions under investigation include: Placebo (OTHER), Tafenoquine (DRUG).
Who is sponsoring clinical trial NCT03320174?
This trial is sponsored by 60 Degrees Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.