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NCT01702376 · ClinicalTrials.gov registry record · Phase 1
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01702376 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 52 participants.
The verdict
NCT01702376, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover study design in healthy male and female subjects. The study consists of screening (28 days), treatment (1 day/dosing session) and follow-up (7 to 14 days) period and the total duration of study participation for each subject will be approximately 9 weeks. Each subject will participate in 4 dosing sessions separated by a minimum 7-day washout period. All subjects will receive single doses of retosiban 100 mg, (treatment A) retosiban 800 mg (Treatment B), moxifloxacin 400 mg (Treatment C) and placebo (Treatment D) in one of the four treatment sequences (ABDC, BCAD, CDBA, DACB) following a Williams design Twelve-lead ECGs and continuous Holter monitoring, clinical laboratory safety tests, vital sign measurements, physical examinations, adverse event reports, and pharmacokinetic samples will be collected throughout the study. In each study period, cardiac conduction will be measured using a 24-hour continuous 12-lead Holter monitor from the morning of Day 1 (dosing) until the morning of Day 2.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin 400 mg
- DRUG Retosiban 100 mg
- DRUG Retosiban 800 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-10-03 |
| Est. Completion | 2013-01-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01702376
The ClinicalTrials.gov registry entry for NCT01702376 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 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 4 interventions - of which Placebo is the first listed.
NCT01702376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01702376 about?
NCT01702376 is a clinical study titled "This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.". This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover study design in healthy male and female subjects. The study consists of screening (28 days), treatment (1 day/dosing session) and follow-up (7 to 14 days) period and the total duration of study participatio...
What is the current status of trial NCT01702376?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2012-10-03. Estimated completion is 2013-01-14.
What interventions are being tested in trial NCT01702376?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin 400 mg (DRUG), Retosiban 100 mg (DRUG), Retosiban 800 mg (DRUG).
Who is sponsoring clinical trial NCT01702376?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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