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

Bayer

Status and phase

Completed

Phase 1

Conditions

Clinical Trial, Phase I

Treatments

Drug: Vilaprisan (BAY1002670)

Other: Itraconazole(ITZ)

Drug: [14C] Vilaprisan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02456129

2014-004929-41 (EudraCT Number)

15250

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Female

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)