A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 425809 in the Blood

Phase 1 Completed 16 enrolled Boehringer Ingelheim

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this trial is to investigate the relative bioavailability of a single dose of BI 425809 when given alone (Reference, B) compared with co-administration (Test, A) on the 7th day of a 10-day treatment with rifampicin following oral administration in healthy male volunteers.

Timeline

Start: 2017-03-28
Primary completion: 2017-06-20
Completion: 2017-06-20

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	Iclepertin	Small molecule	25 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral

Indications

No indication recorded.