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

Phase 1 Completed 14 enrolled Bayer

NaSingle-groupOpen-label

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.

Timeline

Start: 2015-07
Primary completion: 2015-09
Completion: 2016-02

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vilaprisan	Other / unclassified	4 mg	Oral

Indications

No indication recorded.