A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Microgynon®; Drug: Aleglitazar; Drug: Placebo

• Registration Number: NCT01615354
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Study Start: 2012-07
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Placebo	Microgynon®	-
Treatment	Microgynon®	-
Treatment	Aleglitazar	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Levonorgestrel: area under the concentration time curve	pre-dose and up to 24 hours post-dose
Pharmacokinetics of ethinyl estradiol: area under the concentration time curve	pre-dose and up to 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics: luteinizing/follicular stimulation hormone concentration	Days 1, 7, 13, 14, 15, 21
Safety: incidence of adverse events	16 weeks