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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832452
• Other study ID #: ID-069-106
• Secondary ID: 2018-004546-42
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2019
• Est. completion date: April 22, 2019

Study information

• Verified date: October 2019
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lucerastat (Treatment A)
2000 and 4000 mg; hard capsules for oral administration

Other:
• Placebo
hard capsules for oral administration

Drug:
• Moxifloxacin
400 mg; film-coated tablets for oral administration
• Lucerastat (Treatment B)
1000 mg; hard capsules for oral administration
• Lucerastat (Treatment C)
4000 mg; hard capsules for oral administration

Locations

Country	Name	City	State
Netherlands	QPS Netherlands B.V.	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

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