Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 61 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02293148
The ClinicalTrials.gov registry entry for NCT02293148 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 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 5 interventions - of which Moxifloxacin 400 mg is the first listed.
NCT02293148 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.