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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: APD356 10 mg; Drug: APD356 20 mg; Drug: APD356 XR-20 mg; Drug: APD356 10 mg matching Placebo; Drug: APD356 20 mg matching Placebo; Drug: APD356 XR-20 mg matching Placebo; Drug: APD356 XR-20 mg (orange tablet); Drug: APD356 XR-20mg (orange tablet, fed state)

• Registration Number: NCT02192515
• Lead Sponsor: Eisai Co., Ltd.

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APD356 10 mg	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.
APD356 10 mg	APD356 10 mg matching Placebo	Subjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
APD356 20 mg	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.
APD356 20 mg	APD356 20 mg matching Placebo	Subjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
APD356 XR-20 mg	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.
APD356 XR-20 mg	APD356 XR-20 mg matching Placebo	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.
APD356 10 mg and APD356 XR-20mg (orange tablet)	APD356 10 mg	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)
APD356 10 mg and APD356 XR-20mg (orange tablet)	APD356 XR-20 mg (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)
APD356 10 mg and APD356 XR-20mg (orange tablet)	APD356 XR-20mg (orange tablet, fed state)	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)

Primary Outcome Measures

Name	Time	Method
Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs	Up to 30 days after last dose
Pharmacokinetics of APD356: Cmax	Up to 96 hours after last dose
Pharmacokinetics of APD356: AUC	Up to 96 hours after last dose
Pharmacokinetics of APD356: tmax	Up to 96 hours after last dose
Pharmacokinetics of APD356: t1/2	Up to 96 hours after last dose