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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

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.

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Detailed Description

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Conditions

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Clinical Trial, Phase I

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Vilaprisan + Itraconazole

Vilaprisan (BAY1002670)

Group Type EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type DRUG

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)

[14C] Vilaprisan

Intervention Type DRUG

an intravenous microtracer dose of \[14C\]Vilaprisan administered together with the 1st single oral dose of Vilaprisan

Itraconazole(ITZ)

Intervention Type OTHER

Itraconazole(ITZ) 200 mg as solution, once daily for 14 days

Interventions

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Vilaprisan (BAY1002670)

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)

Intervention Type DRUG

[14C] Vilaprisan

an intravenous microtracer dose of \[14C\]Vilaprisan administered together with the 1st single oral dose of Vilaprisan

Intervention Type DRUG

Itraconazole(ITZ)

Itraconazole(ITZ) 200 mg as solution, once daily for 14 days

Intervention Type OTHER

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)

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes