A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers

Phase 1 Completed 36 enrolled Genzyme, a Sanofi Company

RandomizedParallel-groupDouble-blindBasic science

Summary

To assess in healthy adult subjects: * The tolerability and safety of ascending repeated oral doses of Genz-682452. * The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses. * The pharmacodynamics of Genz-682452 after ascending repeated oral doses.

Timeline

Start: 2012-10
Primary completion: 2013-02
Completion: 2013-02

Publications

Peterschmitt MJ, Crawford NPS, Gaemers SJM, Ji AJ, Sharma J, Pham TT. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Jan;10(1):86-98. doi: 10.1002/cpdd.865. Epub 2020 Aug 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venglustat	Small molecule	5 mg	Oral
Subject	Venglustat	Small molecule	10 mg	Oral
Subject	Venglustat	Small molecule	20 mg	Oral

Indications

No indication recorded.