Study Completed

Endometriosis

Bayer Identifier:

17773

ClinicalTrials.gov Identifier:

NCT02975440

EudraCT Number:

Not Available

EU CT Number:

Not Available

Drug-drug interaction study between orally administered rifampicin and vilaprisan

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.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years

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

Trial Dates

November 2016 - April 2017

Phase

Phase 1

Could I Receive a placebo

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Berlin, 13353, Germany

Primary Outcome

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
Safety Issue:
No
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
Safety Issue:
No
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
Safety Issue:
No
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
Safety Issue:
No

Trial design

Non-randomized, non-blinded, non-placebo-controlled study to investigate the influence of repeated daily administration of 600 mg rifampicin given once daily over 11 days on the pharmacokinetics, safety, and tolerability of a single oral dose of 4 mg vilaprisan in healthy postmenopausal women.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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