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Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Rifampicin
Midazolam
BAY1002670_Vilaprisan
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometriosis focused on measuring Vilaprisan, PK, rifampicin, midazolam,, CYP3A4 induction, drug-drug interaction

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment A (Period 1): a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam Treatment B (Period 2): 600 mg Rifampicin once daily (qd) for 7 days followed by administration of a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam followed by 600 mg Rifampicin 12 hours after Vilaprisan and Midazolam administration and continued dosing of 600 mg Rifampicin once daily for 3 days

Outcomes

Primary Outcome Measures

AUC of Vilaprisan in plasma with co-medication Rifampicin
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

Secondary Outcome Measures

Full Information

First Posted
November 4, 2016
Last Updated
June 30, 2017
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02975440
Brief Title
Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
January 27, 2017 (Actual)
Study Completion Date
April 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Vilaprisan, PK, rifampicin, midazolam,, CYP3A4 induction, drug-drug interaction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment A (Period 1): a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam Treatment B (Period 2): 600 mg Rifampicin once daily (qd) for 7 days followed by administration of a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam followed by 600 mg Rifampicin 12 hours after Vilaprisan and Midazolam administration and continued dosing of 600 mg Rifampicin once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Intervention Description
11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam
Intervention Type
Drug
Intervention Name(s)
BAY1002670_Vilaprisan
Intervention Description
2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

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Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

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