Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)

Phase 1 Completed 96 enrolled Boehringer Ingelheim

RandomizedSingle-groupDouble-blindTreatment

Summary

The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.

Timeline

Start: 2015-01-15
Primary completion: 2015-11-16
Completion: 2015-11-16

Publications

Moschetti V, Schlecker C, Wind S, Goetz S, Schmitt H, Schultz A, Liesenfeld KH, Wunderlich G, Desch M. Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics. Clin Drug Investig. 2018 Aug;38(8):737-750. doi: 10.1007/s40261-018-0660-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iclepertin	Small molecule	10 mg	Oral
Subject	Iclepertin	Small molecule	25 mg	Oral
Subject	Iclepertin	Small molecule	50 mg	Oral
Subject	Iclepertin	Small molecule	75 mg	Oral

Indications

No indication recorded.