A Phase 1 Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs
研究概览
简要总结
The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center, placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single center, randomized, open-label study that consists of two sequential two-way crossover studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
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
- 20 Years 至 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
APD356 10 mg
Subjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
干预措施: APD356 10 mg (Drug)
APD356 10 mg
Subjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
干预措施: APD356 10 mg matching Placebo (Drug)
APD356 20 mg
Subjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
干预措施: APD356 20 mg (Drug)
APD356 20 mg
Subjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
干预措施: APD356 20 mg matching Placebo (Drug)
APD356 XR-20 mg
Subjects will be randomized to APD356 XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast.
干预措施: APD356 XR-20 mg (Drug)
APD356 XR-20 mg
Subjects will be randomized to APD356 XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast.
干预措施: APD356 XR-20 mg matching Placebo (Drug)
APD356 10 mg and APD356 XR-20mg (orange tablet)
Subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
干预措施: APD356 10 mg (Drug)
APD356 10 mg and APD356 XR-20mg (orange tablet)
Subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
干预措施: APD356 XR-20 mg (orange tablet) (Drug)
APD356 10 mg and APD356 XR-20mg (orange tablet)
Subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
干预措施: APD356 XR-20mg (orange tablet, fed state) (Drug)
结局指标
主要结局
Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs
时间窗: Up to 30 days after last dose
Pharmacokinetics of APD356: Cmax
时间窗: Up to 96 hours after last dose
Pharmacokinetics of APD356: AUC
时间窗: Up to 96 hours after last dose
Pharmacokinetics of APD356: tmax
时间窗: Up to 96 hours after last dose
Pharmacokinetics of APD356: t1/2
时间窗: Up to 96 hours after last dose
次要结局
未报告次要终点