Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects

Phase 1 Completed 16 enrolled Boehringer Ingelheim

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects

Timeline

Start: 2015-01-29
Primary completion: 2015-03-24
Completion: 2015-03-24

Publications

Desch M, Wunderlich G, Goettel M, Goetz S, Liesenfeld KH, Chan TS, Rosenbrock H, Sennewald R, Link J, Keller S, Wind S. Effects of Cytochrome P450 3A4 Induction and Inhibition on the Pharmacokinetics of BI 425809, a Novel Glycine Transporter 1 Inhibitor. Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):91-103. doi: 10.1007/s13318-021-00723-y. Epub 2021 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 425809	Unknown	25 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	Oral

Indications

No indication recorded.