Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 2, 2015

Primary Completion Date

April 17, 2015

Study Completion Date

April 17, 2015

Conditions
Obstetric Labour, Premature
Interventions
DRUG

Retosiban solution for Infusion

Retosiban will be supplied as clear, colorless IV solution for infusion in 5 mL vial with a unit dose strength of 15 milligrams per milliliter (mg/mL) (each 5 mL vial contains 75 mg retosiban), dosed at up to 300 mg over 48 h infusion

DRUG

Placebo

Placebo will be supplied as a clear, colorless IV solution for infusion with a unit dose strength of 0.9% sodium chloride (NaCl) normal saline

Trial Locations (1)

91206

GSK Investigational Site, Glendale

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02377414 - Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women | Biotech Hunter | Biotech Hunter