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NCT02658435 · ClinicalTrials.gov registry record · Phase 1
Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 486
- Enrollment target
NCT02658435: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02658435 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 486 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (710% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02658435, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 486 participants
- Enrollment target
Study Summary
The study aims to provide evidence of retinal safety to support the use of tafenoquine as a potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax) malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be conducted as a single masked, randomized, placebo-controlled, parallel group design. It will assess retinal changes from baseline using spectral domain optical coherence tomography (OCT) and fundus auto fluorescence (FAF) at Month 3 (90 days) post-dose in adult healthy volunteers (participants). A placebo control group will be used to compare the results in the TQ group. Interim analysis will be conducted after completing 100 out of 300 participants in TQ group and 50 out of 150 participants in matched placebo.
Primary Outcome
The change from baseline will be assessed as a binomial output as, Yes or No. Spectral domain OCT (SD-OCT) images/scan will be obtained. For Central subfield thickness and Central retinal lesion thickness, change from baseline of at least 40 microns (µ) will be consider 'Yes'. Central Retinal Lesion Thickness is defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris measured in the central 1millimeter (mm) of the centre scan
Interventions
- DRUG Tafenoquine 150 mg
- DRUG Matched placebo 150mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2016-02-02 |
| Est. Completion | 2017-09-14 |
| Phase | Phase 1 |
What the finished NCT02658435 record still lists
NCT02658435 is an interventional study that assigns participants to a tested intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (710% higher).
The record links to 0 conditions, and to 2 interventions - of which Tafenoquine 150 mg is the first listed.
NCT02658435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02658435 about?
NCT02658435 is a clinical study titled "Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)". The study aims to provide evidence of retinal safety to support the use of tafenoquine as a potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax) malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be conducted as a single masked, r...
What is the current status of trial NCT02658435?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 486 participants. The study started on 2016-02-02. Estimated completion is 2017-09-14.
What interventions are being tested in trial NCT02658435?
The interventions under investigation include: Tafenoquine 150 mg (DRUG), Matched placebo 150mg (DRUG).
Who is sponsoring clinical trial NCT02658435?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02658435's enrollment target sits among peer trials
486 48th of 2000 higher than 1,953 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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