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NCT02751294 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02751294: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02751294 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02751294, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets exhibiting different dissolution profiles in healthy subjects. This is a single-centre, 2-arm, randomized open-label, parallel-group study in healthy subjects. All subjects will arrive in the unit approximately 24 hours prior to dosing and will be discharged after the 72-hour post-dose assessments are completed. Subjects will return for outpatient visits on Days 7, 14, 21, 28, and 56 after dosing. A total of 14 subjects (n=7 subjects in each arm) are planned to be enrolled. All subjects will receive a single dose of study medication (2x150 mg TQ tablets + 30 mg TQ SIL in solution) and participate through a 56-day post dose follow-up visit. To enable the application of peripheral microsampling in planned paediatric studies, a comparison of the measured pharmacokinetic (PK) exposure via peripheral blood collection (via microsampling) to venous collection will also be performed in this study.
Primary Outcome
Blood samples for PK analysis of TQ will be collected for evaluation of ratio of the geometric means (90% Confidence Interval \[CI\]) for the area under plasma concentration-time curve from 0 to time t (AUC \[0-t\]) and area under the concentration-time curve from 0 to infinity (AUC\[0-inf\]) for the treatment group dissolution profile X compared to Control.
Interventions
- DRUG Tafenoquine Control
- DRUG Tafenoquine dissolution profile X
- DRUG Tafenoquine SIL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-05 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT02751294 record still lists
NCT02751294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Tafenoquine Control is the first listed.
NCT02751294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02751294 about?
NCT02751294 is a clinical study titled "A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution". This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets exhibiting different dissolution profiles in healthy subjects. This is a single-centre, 2-arm, randomized open-labe...
What is the current status of trial NCT02751294?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-05. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02751294?
The interventions under investigation include: Tafenoquine Control (DRUG), Tafenoquine dissolution profile X (DRUG), Tafenoquine SIL (DRUG).
Who is sponsoring clinical trial NCT02751294?
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 NCT02751294's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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