Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

NCT02975440 | Completed Phase 1

• 1 other identifier: 17773
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Vilaprisan; PK; rifampicin; midazolam,; CYP3A4 induction; drug-drug interaction

Outcome Measures

Primary Outcomes (4)

• AUC of Vilaprisan in plasma with co-medication Rifampicin

  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

• Cmax of Vilaprisan in plasma with co-medication Rifampicin

  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

• AUC of Vilaprisan in plasma without co-medication Rifampicin

  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

• Cmax of Vilaprisan in plasma without co-medication Rifampicin

  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

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Rifampicin; Drug: Midazolam; Drug: BAY1002670_Vilaprisan

Interventions

Rifampicin DRUG

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

Treatment

Midazolam DRUG

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

Treatment

BAY1002670_Vilaprisan DRUG

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

Treatment

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Rifampin; Midazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 29, 2016
• Study Start: November 10, 2016
• Primary Completion: January 27, 2017
• Study Completion: April 11, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

DE (1)