NCT02213029 - A Study to Evaluate Pharmacokinetics, Pharmacodynamics and Tissue Concentrations of Epelsiban | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 28, 2014

Primary Completion Date

February 7, 2016

Study Completion Date

February 7, 2016

Conditions

Embryo Transfer

Interventions

DRUG

Epelsiban

White to off white Oral tablets with unit dose strength of 5 mg or 25 mg for dose level of 25 mg, 150mg or \>150mg

DRUG

Placebo

White to off white oral placebo tablets to match 5mg epelsiban

DRUG

Oxytocin

Oxytocin for IV infusion (at doses of 5, 10, and 20 milliunits), IV bolus (5 IU administered IV as a bolus over 15 seconds) and IM (5 IU administered IM).

DRUG

Ortho-Cylcen (21)® tablet

White, blue or green tablets for oral administration per product insert to synchronize the menstrual cycles with ovulation. Ortho Cyclen (21) ® is a registered trademark of Johnson \& Johnson

Trial Locations (2)

21225

GSK Investigational Site, Baltimore

91206

GSK Investigational Site, Glendale