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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02456129
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : March 2, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Clinical Trial, Phase I Drug: Vilaprisan (BAY1002670) Drug: [14C] Vilaprisan Other: Itraconazole(ITZ) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vilaprisan + Itraconazole
Vilaprisan (BAY1002670)
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

Primary Outcome Measures :
  1. 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 ]
  2. Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ. [ Time Frame: up to 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02456129

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United Kingdom
Leeds, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT02456129     History of Changes
Other Study ID Numbers: 15250
2014-004929-41 ( EudraCT Number )
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016

Keywords provided by Bayer:
Clinical Trial, Phase I

Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors