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PK Study of T-817 in Subjects With Hepatic Impairment

NCT ID: NCT02693197

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Hepatic Impairment

Keywords

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1:T-817MA

Mild hepatic impairment subjects

Group Type EXPERIMENTAL

T-817MA

Intervention Type DRUG

A single oral dose of 448 mg

Cohort 2:T-817MA

Healthy subjects matched to subjects in Cohort 1

Group Type EXPERIMENTAL

T-817MA

Intervention Type DRUG

A single oral dose of 448 mg

Cohort 3:T-817MA

Moderate hepatic impairment subjects

Group Type EXPERIMENTAL

T-817MA

Intervention Type DRUG

A single oral dose of 448 mg

Cohort 4:T-817MA

Healthy subjects matched to subjects in Cohort 3

Group Type EXPERIMENTAL

T-817MA

Intervention Type DRUG

A single oral dose of 448 mg

Cohort 5 :T-817MA

Severe hepatic impairment subjects

Group Type EXPERIMENTAL

T-817MA

Intervention Type DRUG

A single oral dose of 448 mg

Cohort 6:T-817MA

Healthy subjects matched to subjects in Cohort 5

Group Type EXPERIMENTAL

T-817MA

Intervention Type DRUG

A single oral dose of 448 mg

Interventions

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T-817MA

A single oral dose of 448 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

For subjects with mild, moderate or severe hepatic impairment

1. Adult male or female, 18 - 75 years of age
2. Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
3. Have mild, moderate or severe defined by Child-Pugh classification hepatic impairment

For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status

Exclusion Criteria

1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
3. History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
4. Female subjects who are pregnant or lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celerion

INDUSTRY

Sponsor Role collaborator

FUJIFILM Toyama Chemical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Preston, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Thomas Marbury, M.D.

Role: PRINCIPAL_INVESTIGATOR

Orlando Clinical Research Center

Locations

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University of Miami

Miami, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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T817MAUS113

Identifier Type: -

Identifier Source: org_study_id