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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 486 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02658435
The ClinicalTrials.gov registry entry for NCT02658435 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tafenoquine 150 mg is the first listed.
NCT02658435 reports 0 study locations.
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.
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