Trial Condition(s):

Endometriosis

Drug-drug interaction study between orally administered rifampicin and vilaprisan

Bayer Identifier:

17773

ClinicalTrials.gov Identifier:

NCT02975440

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 

Trial Design