A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects

Phase 1 Completed 37 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 after multiple dosing. Also, the potential effect of food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.

Timeline

Start: 2003-12
Primary completion: 2004-05
Completion: 2004-05

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	200 mg	—
Subject	Lucerastat	Small molecule	500 mg	—
Subject	Lucerastat	Small molecule	1000 mg	—

Indications

No indication recorded.