check_circleStudy 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
  • - 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
  • - 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
14
Trial Dates
July 2015 - February 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Covance Clinical Research UnitLeeds, 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.
    date_rangeTime Frame:
    up to 14 days
    enhanced_encryption
    Safety Issue:
    No
  • Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ.
    date_rangeTime Frame:
    up to 14 days
    enhanced_encryption
    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
1

Additional Information

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