NCT02975440 - Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

12

Conditions

Endometriosis

Interventions

RifampicinDRUG

11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.

MidazolamDRUG

2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam

BAY1002670_VilaprisanDRUG

2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Berlin, Germany

Outcomes

Primary Outcomes

AUC of Vilaprisan in plasma with co-medication Rifampicin

Time frame: 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

Time frame: 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

AUC of Vilaprisan in plasma without co-medication Rifampicin

Time frame: 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 without co-medication Rifampicin

Time frame: 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