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Completed

NCT Number: NCT02456129

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

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.

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Key information

Conditions

Clinical Trial, Phase I

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vilaprisan (BAY1002670)

Drug

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)

[14C] Vilaprisan

Drug

an intravenous microtracer dose of [14C]Vilaprisan administered together with the 1st single oral dose of Vilaprisan

Itraconazole(ITZ)

Other

Itraconazole(ITZ) 200 mg as solution, once daily for 14 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 28, 2015
Registry last updated
Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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