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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03832452

Enrollment

Registered

2019-02-06

Start date

2019-02-14

Completion date

2019-04-22

Last updated

2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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)

Interventions

DRUGLucerastat (Treatment A)

2000 and 4000 mg; hard capsules for oral administration

OTHERPlacebo

hard capsules for oral administration

DRUGMoxifloxacin

400 mg; film-coated tablets for oral administration

DRUGLucerastat (Treatment B)

1000 mg; hard capsules for oral administration

DRUGLucerastat (Treatment C)

4000 mg; hard capsules for oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study (Part A: parallel, 2 treatments; Part B: crossover, 4 treatments)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Part A only: \- Healthy male subjects aged between 18 and 55 years. Part B only: * Healthy male and female subjects aged between 18 and 55 years. * Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of the first period. They must consistently and correctly use a highly effective method of contraception, or be sexually inactive, or have a vasectomized partner. * Women of nonchildbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis). Part A and B: * Signed informed consent prior to any study-mandated procedure. * Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening. Body weight at least 50.0 kg at Screening and prior to first study treatment administration. * Healthy on the basis of medical history, physical examination, cardiovascular assessments and clinical laboratory tests.

Exclusion criteria

Part B only: * Known hypersensitivity to moxifloxacin or any of its excipients. * Pregnant or lactating women. * Women planning to become pregnant. Part A and B: * Previous exposure to lucerastat. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. * History or presence of rhythm disorders.

Design outcomes

Primary

Measure	Time frame	Description
Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)	From 1 h pre-dose to 36 hour after study treatment administration (duration: up to 37 hours)	QTcF = QT interval corrected with Fridericia's formula; ΔΔQTcF = Placebo-corrected change-from-baseline QTcF

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026