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PK Study of T-817 in Subjects With Hepatic Impairment

NCT02693197 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-11-24

No results posted yet for this study

Summary

The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.

The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.

Conditions

  • Healthy
  • Hepatic Impairment

Interventions

DRUG

T-817MA

A single oral dose of 448 mg

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • FUJIFILM Toyama Chemical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Richard Preston, M.D. · University of Miami

  • Thomas Marbury, M.D. · Orlando Clinical Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-08-31
Completion
2016-08-31
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 NCT02693197 on ClinicalTrials.gov