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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lucerastat (Treatment A); Drug: Moxifloxacin; Other: Placebo; Drug: Lucerastat (Treatment C); Drug: Lucerastat (Treatment B)

• Registration Number: NCT03832452
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Study Start: 2019-02-14
• Primary Completion: 2019-04-22
• Study Completion: 2019-04-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Treatment 1	Lucerastat (Treatment A)	A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3
Part B: Treatment A	Moxifloxacin	A single oral dose of 400 mg moxifloxacin
Part A: Treatment 2	Placebo	A single oral dose of placebo on Day 1 and 3
Part B: Treatment C	Lucerastat (Treatment C)	A single oral dose of 4000 mg lucerastat
Part B: Treatment D	Placebo	A single oral dose of placebo
Part B: Treatment B	Lucerastat (Treatment B)	A single oral dose of 1000 mg lucerastat

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

QPS Netherlands B.V.; 🇳🇱 Groningen, Netherlands