CompletedPhase 1

Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

Germany12 participantsStarted 2016-11-10

Plain-language 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.

Who can participate

Age range45 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

AUC of Vilaprisan in plasma with co-medication Rifampicin

Timeframe: blood sampling for pharmacokinetics of Vilaprisan (LC-MS/MS) at the following time points post administration of Vilaprisan and Midazolam: 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,15 hour, thereafter daily sampling up to 14 days

Cmax of Vilaprisan in plasma with co-medication Rifampicin

AUC of Vilaprisan in plasma without co-medication Rifampicin

Cmax of Vilaprisan in plasma without co-medication Rifampicin

Trial details

NCT IDNCT02975440

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01-27

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