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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
One tablet of APD356 10 mg will be orally administered in fasted state.
One tablet of APD356 XR-20 mg will be orally administered in fasted state.
One tablet of APD356 10 mg matching placebo will be orally administered in fasted state.
One tablet of APD356 XR matching placebo will be orally administered in fasted state.
Two tablets of APD356 10 mg will be orally administered in fasted state.
Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state.
One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state.
One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal.
Unnamed facility
Toshima-Ku, Tokyo, Japan
Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs
Time frame: Up to 30 days after last dose
Pharmacokinetics of APD356: Cmax
Time frame: Up to 96 hours after last dose
Pharmacokinetics of APD356: tmax
Time frame: Up to 96 hours after last dose
Pharmacokinetics of APD356: AUC
Time frame: Up to 96 hours after last dose
Pharmacokinetics of APD356: t1/2
Time frame: Up to 96 hours after last dose
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