NCT02500953

A Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

\<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

Conditions

• Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects

Interventions

Type	Name	Description
DRUG	ASP3325
DRUG	Placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2015-07-17
• Last updated: 2015-07-17

Locations

1 site across 1 country: Japan