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NCT02293148 · ClinicalTrials.gov registry record · Phase 1
Single Dose, Pharmacokinetic, Safety, Tolerability and QTc Study of GSK1278863 in Healthy Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT02293148: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02293148 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02293148, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study is being performed to comply with regulatory requirements that all new non-antiarrhythmic drugs must be assessed for potential effects on cardiac repolarization through electrocardiographic evaluation in a 'Thorough QT/ Corrected QT interval (TQT)' study. This will be a two part study, Part A will be an open-label, single oral dose study design in order to evaluate the pharmacokinetics, safety and tolerability of a 500 milligram (mg) dose of GSK1278863 and Part B will be a single-blind, randomized, placebo-controlled, single, oral dose, four-way crossover study design. Parts A and B will be conducted in healthy adult subjects with 12-lead electrocardiograms (ECGs), clinical laboratory safety tests, vital sign measurements, physical examinations, adverse event reports, and pharmacokinetic samples collected throughout the study.
Primary Outcome
Plasma concentrations of GSK1278863 and its metabolites (GSK2391220 \[M2\], GSK2506104 \[M3\], GSK2487818 \[M4\], GSK2506102 \[M5\], GSK2531398 \[M6\], and GSK2531401 \[M13\]) and derived pharmacokinetic parameters including maximum observed concentration (Cmax), Time of occurrence of Cmax (tmax), Area under the concentration-time curve (AUC)
Interventions
- DRUG Moxifloxacin 400 mg
- DRUG GSK1278863 75 mg
- DRUG GSK1278863 500 mg
- DRUG Placebo matching GSK1278863
- DRUG Placebo matching Moxifloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2014-11-17 |
| Est. Completion | 2015-03-10 |
| Phase | Phase 1 |
What the finished NCT02293148 record still lists
NCT02293148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Moxifloxacin 400 mg is the first listed.
NCT02293148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02293148 about?
NCT02293148 is a clinical study titled "Single Dose, Pharmacokinetic, Safety, Tolerability and QTc Study of GSK1278863 in Healthy Volunteers". This study is being performed to comply with regulatory requirements that all new non-antiarrhythmic drugs must be assessed for potential effects on cardiac repolarization through electrocardiographic evaluation in a 'Thorough QT/ Corrected QT interval (TQT)' study. This will be a two part study, Pa...
What is the current status of trial NCT02293148?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2014-11-17. Estimated completion is 2015-03-10.
What interventions are being tested in trial NCT02293148?
The interventions under investigation include: Moxifloxacin 400 mg (DRUG), GSK1278863 75 mg (DRUG), GSK1278863 500 mg (DRUG), Placebo matching GSK1278863 (DRUG), Placebo matching Moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT02293148?
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 NCT02293148's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 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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