A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of Genz-682452 With a Pilot Investigation of Food Effect in Healthy Adult Male Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- Number of participants with adverse events in Part 1
研究概览
简要总结
The objectives of this study are to assess the tolerability, safety and pharmacokinetic parameters of Genz-682452 in healthy adult males, in two parts.
Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential ascending single dose study;
Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment crossover study with a minimum wash-out period; to obtain preliminary information on the pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and fasted conditions.
Subjects are not allowed to participate in more than 1 part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m^2, inclusive.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- •Blood donation, greater than 100 mL, within 2 months before inclusion.
- •Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- •History or presence of drug or alcohol abuse.
- •Unable to stop smoking cigarettes during the study.
- •Excessive consumption of beverages containing xanthine bases.
研究组 & 干预措施
Part 1 (GZFD00111/TDU12766): Genz-682452
Participants will receive a single oral dose of Genz-682452. Six ascending single doses and an optional seventh dose under fasted conditions will be used.
干预措施: Genz-682452 (Drug)
Part 1 (GZFD00111/TDU12766): Placebo
Participants will receive a single oral dose of placebo.
干预措施: Placebo (Drug)
Part 2 (GZFD00211/FED12767): Genz-682452
Participants will receive two single doses of Genz-682452 separated by a 7-day wash-out period, one dose given under fed (standardized high-fat breakfast) and one under fasted conditions. The dose will be based on the blind review of the safety/tolerability/pharmacokinetic data of single dose level cohorts in Part 1.
干预措施: Genz-682452 (Drug)
结局指标
主要结局
Number of participants with adverse events in Part 1
时间窗: Up to 4 weeks
Number of participants with adverse events in Part 2
时间窗: Up to 5 weeks
次要结局
- Pharmacokinetics Plasma Parameters for Part 1 as measured by Cmax, tmax, AUC last, AUC, t1/2z, Vss/F, CL/F(Day 1 through Day 5)
- Pharmacokinetics Urine Parameters for Part 1 as measured by assessment of Genz-682452 urinary excretion, Ae0-t, fe0-t(Day 1 through Day 5)
- Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z(Day 1 to Day 3)