NCT02703181

Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban Administered in Repeat Doses in Healthy Women Volunteers

A Randomized, Placebo-controlled, Double-Blind (Sponsor Unblind), Repeat Dose, Ascending Cohort, Dose Escalation Phase I Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban and Its Major Metabolite in Healthy Women Volunteers Following Administration of Repeat Dosing of Epelsiban

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The current study is designed to assess the safety, tolerability and pharmacokinetics (PK) of additional repeat doses of epelsiban in healthy females, and will be the first dosing experience of repeat dosing at higher doses in women with this compound. This study is a 14 day, randomized, placebo-controlled, double blind (sponsor unblind), repeat dose, ascending cohort, dose escalation study in healthy, female volunteers. Upon successful completion of the Screening period, a subject will be enrolled in the study. The study will be composed of three periods: Screening, Treatment and Follow-up. A subject's total time involved in the study will be approximately six weeks. Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort. Ten subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo (n=2).

Conditions

• Embryo Transfer

Interventions

Type	Name	Description
DRUG	Epelsiban (GSK557296)	White to off-white 0.270 inches x 0.700 inches oblong film coated tablet containing 25 mg or 100 mg epelsiban. To be swallowed whole with water, not to be chewed.
DRUG	Placebo to match GSK557296	White to off-white 0.270 inches x 0.700 inches oblong film coated Tablet containing placebo. To be swallowed whole with water, not to be chewed.

Timeline

• Start date: 2015-07-09
• Primary completion: 2015-09-10
• Completion: 2015-09-10
• First posted: 2016-03-09
• Last updated: 2018-09-13

Locations

1 site across 1 country: United States