Study Completed

Clinical Trial, Phase I

Bayer Identifier:

15250

ClinicalTrials.gov Identifier:

NCT02456129

EudraCT Number:

2014-004929-41

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Female

Age

45 - 70 Years

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

July 2015 - February 2016

Phase

Phase 1

Could I Receive a placebo

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Covance Clinical Research Unit	Leeds, LS2 9LH, United Kingdom

Primary Outcome

Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.
Time Frame:
up to 14 days
Safety Issue:
No
Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ.
Time Frame:
up to 14 days
Safety Issue:
No

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.