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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

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ClinicalTrials.gov Identifier: NCT02456129
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE May 26, 2015
First Posted Date  ICMJE May 28, 2015
Last Update Posted Date March 2, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • 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 ]
  • Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ. [ Time Frame: up to 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02456129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Clinical Trial, Phase I
Intervention  ICMJE
  • Drug: Vilaprisan (BAY1002670)
    single oral doses of 4 mg tablet Vilaprisan, administered once without the comedication of ITZ (period 1) and once with the comedication of ITZ (period 2)
  • Drug: [14C] Vilaprisan
    an intravenous microtracer dose of [14C]Vilaprisan administered together with the 1st single oral dose of Vilaprisan
  • Other: Itraconazole(ITZ)
    Itraconazole(ITZ) 200 mg as solution, once daily for 14 days
Study Arms  ICMJE Experimental: Vilaprisan + Itraconazole
Vilaprisan (BAY1002670)
Interventions:
  • Drug: Vilaprisan (BAY1002670)
  • Drug: [14C] Vilaprisan
  • Other: Itraconazole(ITZ)
Publications * Schultze-Mosgau MH, Höchel J, Prien O, Zimmermann T, Brooks A, Bush J, Rottmann A. Characterization of the Pharmacokinetics of Vilaprisan: Bioavailability, Excretion, Biotransformation, and Drug-Drug Interaction Potential. Clin Pharmacokinet. 2018 Aug;57(8):1001-1015. doi: 10.1007/s40262-017-0607-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02456129
Other Study ID Numbers  ICMJE 15250
2014-004929-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP