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
Phase 1
Completed
- Conditions
- Clinical Trial, Phase I
- Interventions
- Registration Number
- NCT02456129
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 14
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
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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)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vilaprisan + Itraconazole Vilaprisan (BAY1002670) Vilaprisan (BAY1002670) Vilaprisan + Itraconazole [14C] Vilaprisan Vilaprisan (BAY1002670) Vilaprisan + Itraconazole Itraconazole(ITZ) Vilaprisan (BAY1002670)
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method