Completed

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

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What is being tested

Retosiban 100 mg

+ Retosiban 800 mg

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+3

+ Female Urogenital Diseases and Pregnancy Complications

+ Obstetric Labor Complications

From 18 to 45 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: June 12, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: October 3, 2012

Actual date on which the first participant was enrolled.

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.

NCT01702376
Principal SponsorGlaxoSmithKline
Last updated: June 12, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsObstetric Labor ComplicationsObstetric Labor, PrematurePregnancy ComplicationsPremature Birth

Criteria

7 inclusion criteria required to participate
A female subject is eligible to participate if she is of: child-bearing potential and agrees to use the contraception methods from time of consent until until 48 hours post last dose; Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method
ALT, alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin greater than ( > ) 1.5x upper limit of normal (ULN) is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Body weight (greater than or equal to) >= 50 kg and body mass index (BMI) within the range 19 to 29.9 kg/m^2
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
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19 exclusion criteria prevent from participating
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug/alcohol screen
A positive test for Human Immunodeficiency Virus (HIV) antibody
A supine blood pressure that is persistently higher than 140/90 millimeters of mercury (mmHg)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Each subject will be randomized to single dose of retosiban 100 mg in one of the four treatment sequences.

Group II

Experimental
Each subject will be randomized to single dose of retosiban 800 mg in one of the four treatment sequences

Group III

Placebo
Each subject will be randomized to single dose of matching placebo in one of the four treatment sequences

Group IV

Active Comparator
Each subject will be randomized to single dose of moxifloxacin 400 mg in one of the four treatment sequences

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

GSK Investigational Site

Baltimore, United StatesOpen GSK Investigational Site in Google Maps
CompletedOne Study Center