NCT01710826已完成1 期
A Single-center, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending 14-day Repeated Oral Doses of Genz-682452 in Healthy Male and Female Subjects
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
To assess in healthy adult subjects:
- The tolerability and safety of ascending repeated oral doses of Genz-682452.
- The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.
- The pharmacodynamics of Genz-682452 after ascending repeated oral doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg inclusive, if female, body mass index between 18.0 and 30.0 kg/m^2, inclusive.
- •Certified as healthy by a comprehensive clinical assessment.
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- •Blood donation, any volume, within 2 months before inclusion.
- •Symptomatic postural hypotension.
- •History or presence of drug or alcohol abuse.
- •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- •Positive result on urine drug screen.
结局指标
主要结局
Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Day 1 through Day 14
次要结局
- Pharmacokinetics as measure by plasma parameters(Day 1 through Day 14)
- Pharmacodynamics as measure by Plasma concentrations of Glucosylceramide (GL-1), Globotriaosylceramide (GL-3) and GM3 ganglioside (GM3)(Day 1, through Day 14)
- Pharmacokinetics Urine parameter as measure by assessment of Genz-682452 in Urine, Ae0-t, fe0-t (Exploratory)(Day 1 through Day 14)
研究者
研究点 (1)
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