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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APD356 10 mg | Experimental | Subjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. |
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| APD356 20 mg | Experimental | Subjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. |
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| APD356 XR-20 mg | Experimental | 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. |
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| APD356 10 mg and APD356 XR-20mg (orange tablet) | Experimental | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD356 10 mg | Drug | One tablet of APD356 10 mg will be orally administered in fasted state. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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: tmax | Up to 96 hours after last dose | |
| Pharmacokinetics of APD356: AUC | Up to 96 hours after last dose | |
| Pharmacokinetics of APD356: t1/2 | Up to 96 hours after last dose |
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Inclusion Criteria
Subjects must meet all of the following criteria to be included in this study:
Non-smoking, healthy Japanese male subjects age greater than or equal to 20 years and less than 55 years old at the time of informed consent. To be considered non-smokers, subject must have discontinued smoking for at least 4 weeks prior to dosing.
BMI greater than or equal to 23 and less than 32 kg/m2 at Screening
a) BMI (kg/m2) = body weight(kg)/[height(m) x height(m)]
Provide written informed consent
Willing and able to comply with all aspects of the protocol
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toshima-Ku | Tokyo | Japan |
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| APD356 XR-20 mg | Drug | One tablet of APD356 XR-20 mg will be orally administered in fasted state. |
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| APD356 10 mg matching Placebo | Drug | One tablet of APD356 10 mg matching placebo will be orally administered in fasted state. |
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| APD356 XR-20 mg matching Placebo | Drug | One tablet of APD356 XR matching placebo will be orally administered in fasted state. |
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| APD356 20 mg | Drug | Two tablets of APD356 10 mg will be orally administered in fasted state. |
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| APD356 20 mg matching Placebo | Drug | Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state. |
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| APD356 XR-20 mg (orange tablet) | Drug | One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state. |
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| APD356 XR-20mg (orange tablet, fed state) | Drug | One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal. |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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