Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

• Status: Completed
• Trial end date: 2017-04-11
• Target enrollment: 0
• Participant gender: Female

Summary

This study will be conducted in a single center, open-label study with a single group fixed sequence design to evaluate the effect of repeated oral administration of 600 mg RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Midazolam; Rifampin

Criteria

Inclusion Criteria:

• Healthy female postmenopausal subjects

• Age: 45 to 65 years (inclusive)

• Body mass index (BMI) : ≥20 and ≤32 kg/m²

• Race: White

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

• Relevant diseases within the last 4 weeks prior to the first drug administration

• Existing chronic diseases requiring medication

• Known or suspected malignant tumors (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal

• Regular use of medicines

• Repeated use of drugs during 1 week before first study drug administration which might affect absorption (e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists)