NCT03832452

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

Prospective, Single-center, Randomized, Double-blind, Placebo-controlled, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lucerastat (Treatment A)	2000 and 4000 mg; hard capsules for oral administration
OTHER	Placebo	hard capsules for oral administration
DRUG	Moxifloxacin	400 mg; film-coated tablets for oral administration
DRUG	Lucerastat (Treatment B)	1000 mg; hard capsules for oral administration
DRUG	Lucerastat (Treatment C)	4000 mg; hard capsules for oral administration

Timeline

• Start date: 2019-02-14
• Primary completion: 2019-04-22
• Completion: 2019-04-22
• First posted: 2019-02-06
• Last updated: 2019-10-31

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study