Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Epelsiban in Healthy Female Volunteers
Status:
Completed
Trial end date:
2015-01-29
Target enrollment:
Participant gender:
Summary
Epelsiban is a potent and selective oxytocin receptor antagonist in development for enhanced
implantation rates during in-vitro fertilization (IVF). This study a non-randomized, open
label study designed to assess the safety, tolerability and pharmacokinetics of additional
repeat doses of epelsiban in healthy females, and will be the first dosing experience of
greater than 200 milligram (mg) as a single dose with this compound. Data from this study
will inform the selection of doses of epelsiban to be used in future clinical studies. This
study will be composed of 3 periods: Screening, Treatment, and Follow-up. The total duration
that a subject involved in the study will be up to 6 weeks. At least 2 cohorts of subjects
will be enrolled in this study and cohorts will be conducted sequentially. Additional cohorts
will be enrolled if determined necessary. A sufficient number of subjects will be screened
for the study to obtain approximately 6 evaluable subjects per cohort.