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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

September 30, 2015

Study Completion Date

February 29, 2016

Conditions

Clinical Trial, Phase I

Interventions

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

Trial Locations (1)

LS2 9LH

Leeds