Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects Clinical Trial
Official title:
A Placebo-controlled, Double-blind, Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Japanese Male and Female Subjects and Caucasian Male Subjects
The objectives of this study are to evaluate the safety and tolerability of a single and multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered three times a day.
<Part 1: Single ascending dose> Primary objective
- To evaluate the safety and tolerability of a single oral dose of ASP3325 in
non-elderly, healthy adult Japanese male and female, and Caucasian male subjects
Secondary objectives
- To evaluate the pharmacokinetics and pharmacodynamics
- To evaluate gender differences in the pharmacokinetics and pharmacodynamics
- To evaluate ethnic differences in the pharmacokinetics and pharmacodynamics between
Japanese and Caucasians
<Part 2: Multiple ascending dose> Primary objective
- To evaluate the safety and tolerability of multiple oral doses of ASP3325 in
non-elderly, healthy adult Japanese male and female subjects
Secondary objectives
- To evaluate the pharmacokinetics and pharmacodynamics
- To evaluate gender differences in the pharmacokinetics and pharmacodynamics
<Part 3: Evaluation of the effect of administration timing> Primary objective
- To evaluate the effect of administration timing on the pharmacodynamics of ASP3325
orally administered three times a day at different administration timings of 30 minutes
before a meal, during a meal, 30 minutes after a meal, and 2 hours after a meal in
non-elderly, healthy adult Japanese male subjects in a crossover design
Secondary objective
- To evaluate the safety and pharmacokinetics
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)