Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

NCT02068690 ↗

Phase 1 Completed 83 enrolled Boehringer Ingelheim

RandomizedCrossoverOpen-labelTreatment

Summary

To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed

Timeline

Start: 2014-03-20
Primary completion: 2014-09-10
Completion: 2014-09-10

Publications

Moschetti V, Desch M, Goetz S, Liesenfeld KH, Rosenbrock H, Kammerer KP, Wunderlich G, Wind S. Safety, Tolerability and Pharmacokinetics of Oral BI 425809, a Glycine Transporter 1 Inhibitor, in Healthy Male Volunteers: A Partially Randomised, Single-Blind, Placebo-Controlled, First-in-Human Study. Eur J Drug Metab Pharmacokinet. 2018 Apr;43(2):239-249. doi: 10.1007/s13318-017-0440-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 425809	Unknown	0.5 mg	Oral
Subject	BI 425809	Unknown	1 mg	Oral
Subject	BI 425809	Unknown	2 mg	Oral
Subject	BI 425809	Unknown	5 mg	Oral
Subject	BI 425809	Unknown	10 mg	Oral
Subject	BI 425809	Unknown	25 mg	Oral
Subject	BI 425809	Unknown	50 mg	Oral
Subject	BI 425809	Unknown	100 mg	Oral
Subject	BI 425809	Unknown	150 mg	Oral

Indications

No indication recorded.