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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Part A: Treatment 2
A single oral dose of placebo on Day 1 and 3
干预措施: Placebo (Other)
Part B: Treatment A
A single oral dose of 400 mg moxifloxacin
干预措施: Moxifloxacin (Drug)
Part A: Treatment 1
A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3
干预措施: Lucerastat (Treatment A) (Drug)
Part B: Treatment B
A single oral dose of 1000 mg lucerastat
干预措施: Lucerastat (Treatment B) (Drug)
Part B: Treatment C
A single oral dose of 4000 mg lucerastat
干预措施: Lucerastat (Treatment C) (Drug)
Part B: Treatment D
A single oral dose of placebo
干预措施: Placebo (Other)
结局指标
主要结局
Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
时间窗: 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
次要结局
未报告次要终点