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Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline

NCT02256033 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-25

No results posted yet for this study

Summary

The purpose of this study is to test whether mild liver impairment affects blood levels of istradefylline in humans. Decreased liver function could possibly increase istradefylline levels.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Istradefylline

One 40 mg-tablet administered on Day 1

Sponsors & Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Marc Cantillon, M.D. · Kyowa Hakko Kirin Pharma, Inc.

  • Amy Zhang, PhD. · Kyowa Hakko Kirin Pharma, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT02256033 on ClinicalTrials.gov