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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456129

Enrollment

Registered

2015-05-28

Start date

2015-07-31

Completion date

2016-02-29

Last updated

2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trial, Phase I

Keywords

Clinical Trial, Phase I

Brief summary

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.

Interventions

DRUGVilaprisan (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)

DRUG[14C] Vilaprisan

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

OTHERItraconazole(ITZ)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026