Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

Endometriosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975440
• Other study ID #: 17773
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2016
• Last updated: June 30, 2017
• Start date: November 10, 2016
• Est. completion date: April 11, 2017

Study information

• Verified date: June 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 11, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Rifampicin
11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.
• Midazolam
2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam
• BAY1002670_Vilaprisan
2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

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