A Study in Healthy Subjects to Investigate Whether Administration of Lucerastat Can Affect Normal Heart Function

Phase 1 Completed 44 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedParallel-groupQuadruple-blindOther

Summary

Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part B: TQT study)

Timeline

Start: 2019-02-14
Primary completion: 2019-04-22
Completion: 2019-04-22

Outcome

Met primary endpoint

paper A QTcF effect > 10 ms was excluded up to lucerastat plasma concentrations of approximately 34.0 µg/mL. PMID 33109218 ↗

Publications

Mueller MS, Sidharta PN, Voors-Pette C, Darpo B, Xue H, Dingemanse J. The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects. Orphanet J Rare Dis. 2020 Oct 27;15(1):303. doi: 10.1186/s13023-020-01582-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lucerastat	Small molecule	1000 mg	Oral
Subject	Lucerastat	Small molecule	2000 mg	Oral
Subject	Lucerastat	Small molecule	4000 mg	Oral
Comparator	Moxifloxacin	Small molecule	400 mg	Oral

Indications

No indication recorded.