Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan

Study Overview
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Brief Summary
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This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI) between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using intravenous microtracer dose of [14C]vilaprisan.

Official Title
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An Open-label Study to Evaluate the Effect of Repeated Oral Administration of 200 mg Itraconazole(ITZ) Given Once Daily Over 14 Days on the Single Oral Dose Pharmacokinetics of Vilaprisan (BAY1002670) as Well as Assessment of Absolute Bioavailability Using a Single Intravenous Microtracer Dose of [14C]Vilaprisan in Healthy Postmenopausal Women

Conditions
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Clinical Trial, Phase I

Intervention / Treatment
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* Drug: Vilaprisan (BAY1002670)
* Drug: [14C] Vilaprisan
* Other: Itraconazole(ITZ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI): 18 ≤ BMI ≤ 32 kg/m² Postmenopausal state revealed by: Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration), in addition: in women < 65 years old, follicle stimulating hormone (FSH) > 40 IU/L Exclusion Criteria: Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal Known or suspected liver diseases Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilaprisan + Itraconazole<br>Vilaprisan (BAY1002670) | Drug: Vilaprisan (BAY1002670)<br>* single oral doses of 4 mg tablet Vilaprisan, administered once without the comedication of ITZ (period 1) and once with the comedication of ITZ (period 2)<br>Drug: [14C] Vilaprisan<br>* an intravenous microtracer dose of [14C]Vilaprisan administered together with the 1st single oral dose of Vilaprisan<br>Other: Itraconazole(ITZ)<br>* Itraconazole(ITZ) 200 mg as solution, once daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ. |  | up to 14 days | 
| Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ. |  | up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Trial, Phase I