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

NCT ID: NCT03832452

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2019-04-22

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)

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Treatment 1

A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3

Group Type EXPERIMENTAL

Lucerastat (Treatment A)

Intervention Type DRUG

2000 and 4000 mg; hard capsules for oral administration

Part A: Treatment 2

A single oral dose of placebo on Day 1 and 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

hard capsules for oral administration

Part B: Treatment A

A single oral dose of 400 mg moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

400 mg; film-coated tablets for oral administration

Part B: Treatment B

A single oral dose of 1000 mg lucerastat

Group Type EXPERIMENTAL

Lucerastat (Treatment B)

Intervention Type DRUG

1000 mg; hard capsules for oral administration

Part B: Treatment C

A single oral dose of 4000 mg lucerastat

Group Type EXPERIMENTAL

Lucerastat (Treatment C)

Intervention Type DRUG

4000 mg; hard capsules for oral administration

Part B: Treatment D

A single oral dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

hard capsules for oral administration

Interventions

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Lucerastat (Treatment A)

2000 and 4000 mg; hard capsules for oral administration

Intervention Type DRUG

Placebo

hard capsules for oral administration

Intervention Type OTHER

Moxifloxacin

400 mg; film-coated tablets for oral administration

Intervention Type DRUG

Lucerastat (Treatment B)

1000 mg; hard capsules for oral administration

Intervention Type DRUG

Lucerastat (Treatment C)

4000 mg; hard capsules for oral administration

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

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QPS Netherlands B.V.

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 33109218 (View on PubMed)

Other Identifiers

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2018-004546-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-069-106

Identifier Type: -

Identifier Source: org_study_id