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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lucerastat (Treatment A)
* Other: Placebo
* Drug: Moxifloxacin
* Drug: Lucerastat (Treatment B)
* Drug: Lucerastat (Treatment C)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Treatment 1<br>A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3 | Drug: Lucerastat (Treatment A)<br>* 2000 and 4000 mg; hard capsules for oral administration<br>|
| Placebo Comparator: Part A: Treatment 2<br>A single oral dose of placebo on Day 1 and 3 | Other: Placebo<br>* hard capsules for oral administration<br>|
| Active Comparator: Part B: Treatment A<br>A single oral dose of 400 mg moxifloxacin | Drug: Moxifloxacin<br>* 400 mg; film-coated tablets for oral administration<br>|
| Experimental: Part B: Treatment B<br>A single oral dose of 1000 mg lucerastat | Drug: Lucerastat (Treatment B)<br>* 1000 mg; hard capsules for oral administration<br>|
| Experimental: Part B: Treatment C<br>A single oral dose of 4000 mg lucerastat | Drug: Lucerastat (Treatment C)<br>* 4000 mg; hard capsules for oral administration<br>|
| Placebo Comparator: Part B: Treatment D<br>A single oral dose of placebo | Other: Placebo<br>* hard capsules for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

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