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OpenTrials
Completed

NCT Number: NCT03832452

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

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)

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS Netherlands B.V.

Groningen, 9713, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lucerastat (Treatment A)

Drug

2000 and 4000 mg; hard capsules for oral administration

Placebo

Other

hard capsules for oral administration

moxifloxacin

Drug

400 mg; film-coated tablets for oral administration

Lucerastat (Treatment B)

Drug

1000 mg; hard capsules for oral administration

Lucerastat (Treatment C)

Drug

4000 mg; hard capsules for oral administration

Primary outcomes

  1. Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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