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

NCT02500953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2015-07-17

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

ASP3325

DRUG

Placebo

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500953 on ClinicalTrials.gov