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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lucerastat (Treatment A); Other: Placebo; Drug: Lucerastat (Treatment C); Drug: Lucerastat (Treatment B); Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03832452

2018-004546-42 (EudraCT Number)

ID-069-106

Details and patient eligibility

About

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)

Enrollment: 44 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 6 patient groups, including a placebo group

Part A: Treatment 1

Experimental group

Description:

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

Treatment:

Drug: Lucerastat (Treatment A)

Part A: Treatment 2

Placebo Comparator group

Description:

A single oral dose of placebo on Day 1 and 3

Treatment:

Other: Placebo

Part B: Treatment A

Active Comparator group

Description:

A single oral dose of 400 mg moxifloxacin

Treatment:

Drug: Moxifloxacin

Part B: Treatment B

Experimental group

Description:

A single oral dose of 1000 mg lucerastat

Treatment:

Drug: Lucerastat (Treatment B)

Part B: Treatment C

Experimental group

Description:

A single oral dose of 4000 mg lucerastat

Treatment:

Drug: Lucerastat (Treatment C)

Part B: Treatment D

Placebo Comparator group

Description:

A single oral dose of placebo

Treatment:

Other: Placebo