Trial Condition(s):
Clinical Trial, Phase I
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 Identifier:
15250
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Covance Clinical Research Unit Leeds, United Kingdom, LS2 9LH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.Timeframe: up to 14 days
- Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ.Timeframe: up to 14 days
Additional Information
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