check_circleStudy 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
  • - Healthy female postmenopausal subjects
    - Age: 45 to 65 years (inclusive)
    - Body mass index (BMI) : ≥20 and ≤32 kg/m²
    - Race: White

  • - 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
12
Trial Dates
November 2016 - April 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • AUC of Vilaprisan in plasma with co-medication Rifampicin
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Cmax of Vilaprisan in plasma with co-medication Rifampicin
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • AUC of Vilaprisan in plasma without co-medication Rifampicin
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Cmax of Vilaprisan in plasma without co-medication Rifampicin
    date_rangeTime 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
    enhanced_encryption
    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
1

Additional Information

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