NCT01702376

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 Randomized, Placebo-Controlled, Double-Blind, Four-way Crossover Study to Assess the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstetric Labour, Premature

Interventions

Type	Name	Description
DRUG	Retosiban 100 mg	Subjects will be administered with single dose of one moxifloxacin placebo tablet, one 100 mg tablet of retosiban and 7 retosiban matched placebo tablets
DRUG	Retosiban 800 mg	Subjects will be administered with single dose of one moxifloxacin placebo tablet and eight 100 mg tablets of retosiban
DRUG	Placebo	Subjects will be administered with one moxifloxacin placebo tablet and eight retosiban matched placebo tablets
DRUG	Moxifloxacin 400 mg	Subjects will be administered with one 400 mg moxifloxacin tablet and eight retosiban matched placebo tablets

Timeline

• Start date: 2012-10-03
• Primary completion: 2013-01-14
• Completion: 2013-01-14
• First posted: 2012-10-08
• Last updated: 2017-06-12

Locations

1 site across 1 country: United States