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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-09-01
• Completion: 2016-02-01
• First posted: 2015-05-28
• Last updated: 2016-03-02

Locations

1 site across 1 country: United Kingdom