Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan
Phase 1
Completed
- Conditions
- Endometriosis
- Interventions
- Registration Number
- NCT02975440
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment BAY1002670_Vilaprisan 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 Treatment Rifampicin 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 Treatment Midazolam 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
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method