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

Bayer0 sites14 target enrollmentJuly 2015

ConditionsClinical Trial, Phase I

InterventionsVilaprisan (BAY1002670)[14C] Vilaprisan Itraconazole(ITZ)

DrugsVilaprisan (BAY1002670)[14C] Vilaprisan

Overview

Phase: Phase 1
Intervention: Vilaprisan (BAY1002670)
Conditions: Clinical Trial, Phase I
Sponsor: Bayer
Enrollment: 14
Primary Endpoint: Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

February 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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)