A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Microgynon®

Drug: Placebo

Drug: Aleglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT01615354

BP25559

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.

Enrollment

18 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female volunteer, 18 to 45 years of age
Body mass index (BMI) between 18.0 and 29.9 kg/m2
Body weight at least 55.0 kg
Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment
Non-smoker for at least 3 months

Exclusion criteria

Currently active gynecological disorder
History of amenorrhea within the previous 3 years
Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors
Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.
History of clinically significant disease that could jeopardize the volunteer safety in the study