A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®

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.

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