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NCT02257398 · ClinicalTrials.gov registry record · Phase 1
Placebo and Moxifloxacin Controlled Cardiac Conduction Study of GSK2140944 in Healthy Volunteers
A Phase 1 study of Infections, Respiratory Tract, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT02257398 is a Phase 1 study of Infections, Respiratory Tract that has completed, run by GlaxoSmithKline. The registered enrollment target is 55 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02257398, a Phase 1 study of Infections, Respiratory Tract, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind crossover, single-dose study to evaluate the effects of a therapeutic (1000 milligram \[mg\]) and supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400 mg) and placebo on the corrected QT interval (QTc) as assessed by continuous 12-lead Holter electrocardiograms (ECGs) in approximately 55 healthy volunteers. All subjects will receive single doses of GSK2140944 1000 mg, GSK2140944 1800 mg, moxifloxacin 400 mg, and placebo in a randomized sequence. A double-dummy approach will be used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo and GSK2140944 or placebo will be administered. Subjects will be screened within 30 days prior to entry to the clinic. Subjects will report to the clinical unit on Day -2 of Period 1 and on Day -1 in subsequent periods. Subjects will remain confined until check out procedures have been completed on Day 3 (5 days confinement in Period 1 and 4 days in the following 3 periods). There will be a washout of at least 7 days between doses. The follow-up visit will occur 7-10 days after the final dose. Total duration of the study (from screening to the follow-up visit) will be approximately 60 days.
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG GSK2140944
- DRUG GSK2140944 placebo
- DRUG Moxifloxacin placebo
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2014-10-06 |
| Est. Completion | 2015-03-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02257398
The ClinicalTrials.gov registry entry for NCT02257398 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 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 1 condition, with Infections, Respiratory Tract appearing as the primary indexed condition, and to 4 interventions - of which Moxifloxacin is the first listed.
NCT02257398 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02257398 about?
NCT02257398 is a clinical study titled "Placebo and Moxifloxacin Controlled Cardiac Conduction Study of GSK2140944 in Healthy Volunteers". This is Phase I, 4-period, randomized, active-and placebo-controlled, double-blind crossover, single-dose study to evaluate the effects of a therapeutic (1000 milligram \[mg\]) and supratherapeutic (1800 mg) dose of GSK2140944 with a positive control (moxifloxacin 400 mg) and placebo on the correcte...
What is the current status of trial NCT02257398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2014-10-06. Estimated completion is 2015-03-02.
What conditions does trial NCT02257398 study?
This clinical trial studies the following conditions: Infections, Respiratory Tract.
What interventions are being tested in trial NCT02257398?
The interventions under investigation include: Moxifloxacin (DRUG), GSK2140944 (DRUG), GSK2140944 placebo (DRUG), Moxifloxacin placebo (DRUG).
Who is sponsoring clinical trial NCT02257398?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02257398 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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