A Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects

Summary

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)

Conditions

• Healthy Subjects

Interventions

DRUG

APD356 10 mg

One tablet of APD356 10 mg will be orally administered in fasted state.

DRUG

APD356 XR-20 mg

One tablet of APD356 XR-20 mg will be orally administered in fasted state.

DRUG

APD356 10 mg matching Placebo

One tablet of APD356 10 mg matching placebo will be orally administered in fasted state.

DRUG

APD356 XR-20 mg matching Placebo

One tablet of APD356 XR matching placebo will be orally administered in fasted state.

DRUG

APD356 20 mg

Two tablets of APD356 10 mg will be orally administered in fasted state.

DRUG

APD356 20 mg matching Placebo

Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state.

DRUG

APD356 XR-20 mg (orange tablet)

One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state.

DRUG

APD356 XR-20mg (orange tablet, fed state)

One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal.

Sponsors & Collaborators

• Eisai Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

54 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2015-11-30

Completion

2016-01-31

Countries

• Japan