Healthy Subjects Clinical Trial
Official title:
A Phase 1 Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects
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)
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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