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Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant

NCT03212313 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-01-04

No results posted yet for this study

Summary

This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Tozadenant

Two 60 mg tablets for a total single study dose of 120 mg

Sponsors & Collaborators

  • Acorda Therapeutics

    collaborator INDUSTRY

  • Biotie Therapies Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Preston, MD · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Drug
Yes

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 NCT03212313 on ClinicalTrials.gov