Healthy Volunteer
Conditions
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.
Interventions
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacodynamics: luteinizing/follicular stimulation hormone concentration | Days 1, 7, 13, 14, 15, 21 |
| Safety: incidence of adverse events | 16 weeks |
Countries
United Kingdom
Outcome results
None listed