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Retosiban PK and Safety in Healthy Japanese Women
NCT02377414Phase 1Completed
- Sponsor
- GSK
- Start
- Mar 2015
- Primary completion
- Apr 2015
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial in Preterm labor (PTL) comparing Cohort 1: Retosiban/Placebo with Cohort 2: Retosiban (2 cohorts). Primary endpoints: Composite of PK parameters of retosiban (AUC, Cmax, t1/2, clearance) at 60 hours and Composite of PK parameters of retosiban metabolite GSK2847065 (AUC, Cmax, t1/2) at 60 hours. Started Mar 2015; status: completed.
02
Drugs
retosiban
03
Conditions
Preterm labor (PTL)
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