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

NCT02456129 | Completed Phase 1

• 2 other identifiers: 152502014-004929-41
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Trial, Phase I

Keywords

Clinical Trial, Phase I

Outcome Measures

Primary Outcomes (2)

• Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.

  up to 14 days

• Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ.

  up to 14 days

Study Arms (1)

Vilaprisan + Itraconazole

EXPERIMENTAL

Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670); Drug: [14C] Vilaprisan; Other: Itraconazole(ITZ)

Interventions

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)

Vilaprisan + Itraconazole

[14C] Vilaprisan DRUG

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

Vilaprisan + Itraconazole

Itraconazole(ITZ) OTHER

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

Vilaprisan + Itraconazole

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

Related Publications (1)

• Schultze-Mosgau MH, Hochel 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.

  PMID: 29330782 DERIVED

MeSH Terms

Interventions

vilaprisan; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 2, 2016

Record last verified: 2016-03

Locations

GB (1)