A Study to Assess the Safety and Pharmacokinetics of Lucerastat (OGT 923) in Healthy Subjects

Phase 1 Completed 39 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedParallel-groupQuadruple-blindOther

Summary

The objectives of this study were to evaluate the safety and tolerability of lucerastat, and to determine its pharmacokinetic profile as single oral doses at different strengths.

Timeline

Start: 2002-10
Primary completion: 2002-12
Completion: 2002-12

Publications

Guerard N, Morand O, Dingemanse J. Lucerastat, an iminosugar with potential as substrate reduction therapy for glycolipid storage disorders: safety, tolerability, and pharmacokinetics in healthy subjects. Orphanet J Rare Dis. 2017 Jan 14;12(1):9. doi: 10.1186/s13023-017-0565-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lucerastat	Small molecule	100 mg	Oral
Subject	Lucerastat	Small molecule	300 mg	Oral
Subject	Lucerastat	Small molecule	500 mg	Oral
Subject	Lucerastat	Small molecule	1000 mg	Oral

Indications

No indication recorded.