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Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

NCT02975440 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

  • Endometriosis

Interventions

DRUG

Rifampicin

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

DRUG

Midazolam

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

DRUG

BAY1002670_Vilaprisan

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2017-01-27
Completion
2017-04-11

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02975440 on ClinicalTrials.gov