A Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK221149A Administered Intravenously and to Investigate the Pharmacokinetics of GSK221149A Administered Orally to Healthy, Pregnant Females With Uncomplicated Pre-term Labor Between 300/7 and 356/7 Weeks' Gestation

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK221149A Administered Intravenously and to Investigate the Pharmacokinetics of GSK221149A Administered Orally to Healthy, Pregnant Females With Uncomplicated Pre-term Labor Between 300/7 and 356/7 Weeks' Gestation

Completed
Phase of Trial: Phase II

Latest Information Update: 19 Jan 2018

At a glance

  • Drugs Retosiban (Primary) ; Retosiban (Primary)
  • Indications Preterm labour
  • Focus Adverse reactions; Pharmacodynamics; Proof of concept
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 29 May 2017 Results of part A of this study (n=29) published in the British Journal of Clinical Pharmacology
    • 29 Jun 2012 Planned number of patients changed from 75 to 100 as reported by European Clinical Trials Database.
    • 14 Oct 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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