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

NCT03832452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-10-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2019-04-22
Completion
2019-04-22
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832452 on ClinicalTrials.gov