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A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects

NCT01929577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-09-16

No results posted yet for this study

Summary

The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.

Conditions

  • Bioavailability of ASP015K
  • Healthy Subjects
  • Pharmacokinetics of ASP015K
  • Food Effect of ASP015K

Interventions

DRUG

ASP015K

oral tablet

Sponsors & Collaborators

  • Janssen Biotech, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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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 NCT01929577 on ClinicalTrials.gov