NCT01941615 - Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel | Crick

Overview

Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

18

Conditions

Healthy

Interventions

faldaprevirDRUG

oral doses for 10 days (period B)

Microgynon®DRUG

oral doses for 23 days (period A+B)

BI 207127DRUG

oral doses for 10 days (period B)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy female subjects * Age 18 to 35 years (inclusive) * Body Mass Index 20-29.9 kg/m2 * Use of hormonal contraception (i.e. oral contraceptives, hormonal contraceptive vaginal ring, but not hormone-containing intrauterine devices, depot injections or contraceptive implants) Exclusion criteria: * Any relevant deviation from healthy conditions * Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study * Positive pregnancy test, pregnancy or planning to become pregnant within 1 month of study completion, or lactation * Any relevant finding of the gynaecological examination * Thrombotic predisposition according to thrombophilic testing * Existing or history of arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation * Existing or history of confirmed venous thromboembolism, family history of venous thromboembolism, and other known risk factors for venous thromboembolism. * Relevant varicosis * No use of an additional contraceptive method from screening examination until 1 month after last study drug administration (acceptable methods are considered to be barrier methods, sexual abstinence, non-hormone-containing intrauterine device, or vasectomisation for the male partner). Use of hormone-containing intrauterine device, depot injection or contraceptive implants * Any history of relevant liver diseases (e.g. disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, or previous or existing liver tumours) * AST (aspartate transaminase) and/or ALT (alanine transaminase) \> 1.5 ULN (upper limit of normal)

Locations (1)

1241.31.2 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Outcomes

Primary Outcomes

AUCtau,ss of Ethinylestradiol

Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).