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 [retosiban] administered orally to healthy, pregnant females with uncomplicated pre-term labor between 30 0/7 and 35 6/7 weeks' gestation.
Phase of Trial: Phase II
Latest Information Update: 13 Sep 2017
At a glance
- Drugs Retosiban (Primary) ; Retosiban (Primary)
- Indications Preterm labour
- Focus Adverse reactions; Pharmacodynamics; Proof of concept
- Sponsors GlaxoSmithKline
- 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.