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A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

NCT ID: NCT01615354

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Microgynon®

Intervention Type DRUG

Multiple oral doses

Placebo

Intervention Type DRUG

Multiple oral doses

Treatment

Group Type EXPERIMENTAL

Aleglitazar

Intervention Type DRUG

Multiple oral doses

Microgynon®

Intervention Type DRUG

Multiple oral doses

Interventions

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Aleglitazar

Multiple oral doses

Intervention Type DRUG

Microgynon®

Multiple oral doses

Intervention Type DRUG

Placebo

Multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BP25559

Identifier Type: -

Identifier Source: org_study_id