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Completed

NCT Number: NCT02975440

Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

rifampicin

Drug

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

midazolam

Drug

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

BAY1002670_Vilaprisan

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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