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NCT01928914 · ClinicalTrials.gov registry record · Phase 1
Tafenoquine Thorough QTc Study in Healthy Subjects
A Phase 1 study of Malaria, Vivax, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 260
- Enrollment target
- 2
- Study locations
NCT01928914: Completed Phase 1 study of Malaria, Vivax, sponsored by GlaxoSmithKline.
NCT01928914 is a Phase 1 study of Malaria, Vivax that has completed, run by GlaxoSmithKline. The registered enrollment target is 260 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928914, a Phase 1 study of Malaria, Vivax, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 260 participants
- Enrollment target
- 2
- Study locations
Study Summary
This will be a randomized, single-blind, placebo controlled, parallel group study. Approximately 260 subjects will be enrolled in five groups. This study is designed to compare the effects of tafenoquine, administered as single dose as well as administered over three consecutive days, on the changes in QT duration to those observed in subjects dosed with either moxifloxacin or placebo.
Primary Outcome
Contineous QTcF will be electronically recorded using holtor monitors. The primary comparison of interest is the mean time-matched change from baseline in QTcF for the difference tafenoquine-placebo for 1200mg dose of tafenoquine at each timepoint.
Conditions Studied
Interventions
- DRUG moxifloxacin
- DRUG Tafenoquine 300mg
- DRUG Tafenoquine 600mg
- DRUG Tafenoquine 1200mg
- DRUG Placebo for Tafenoquine
Study Locations (2)
California
- GSK Investigational Site - Culver City
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2011-07-26 |
| Est. Completion | 2012-06-04 |
| Phase | Phase 1 |
What the finished NCT01928914 record still lists
NCT01928914 is an interventional study that assigns participants to a tested intervention. The registered 260 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 (333% higher).
The record links to 1 condition, with Malaria, Vivax appearing as the primary indexed condition, and to 5 interventions - of which moxifloxacin is the first listed.
NCT01928914 reports a single indexed study location in California, Maryland.
Frequently Asked Questions
What is clinical trial NCT01928914 about?
NCT01928914 is a clinical study titled "Tafenoquine Thorough QTc Study in Healthy Subjects". This will be a randomized, single-blind, placebo controlled, parallel group study. Approximately 260 subjects will be enrolled in five groups. This study is designed to compare the effects of tafenoquine, administered as single dose as well as administered over three consecutive days, on the changes...
What is the current status of trial NCT01928914?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2011-07-26. Estimated completion is 2012-06-04.
What conditions does trial NCT01928914 study?
This clinical trial studies the following conditions: Malaria, Vivax.
What interventions are being tested in trial NCT01928914?
The interventions under investigation include: moxifloxacin (DRUG), Tafenoquine 300mg (DRUG), Tafenoquine 600mg (DRUG), Tafenoquine 1200mg (DRUG), Placebo for Tafenoquine (DRUG).
Who is sponsoring clinical trial NCT01928914?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01928914 being conducted?
This trial has 2 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928914's enrollment target sits among peer trials
260 160th of 2000 higher than 1,834 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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