Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin

Phase 1 Completed 13 enrolled Boehringer Ingelheim

NaCrossoverOpen-labelTreatment

Summary

To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)

Timeline

Start: 2015-09-07
Primary completion: 2015-10-30
Completion: 2015-10-30

Publications

Desch M, Schlecker C, Hohl K, Liesenfeld KH, Chan T, Muller F, Wunderlich G, Keller S, Ishiguro N, Wind S. Pharmacokinetic-Interactions of BI 425809, a Novel Glycine Transporter 1 Inhibitor, With Cytochrome P450 and P-Glycoprotein Substrates: Findings From In Vitro Analyses and an Open-Label, Single-Sequence Phase I Study. J Clin Psychopharmacol. 2023 Mar-Apr 01;43(2):113-121. doi: 10.1097/JCP.0000000000001656. Epub 2023 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Digoxin	Other / unclassified	—	Oral
Subject	Iclepertin	Small molecule	25 mg	—
Subject	Midazolam	Small molecule	—	Oral
Subject	Omeprazole	Other / unclassified	—	Oral
Subject	Warfarin	Small molecule	—	Oral

Indications

No indication recorded.