A PK and Safety Study in Subjects With Hepatic Impairment

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-05-31

Brief Summary

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Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.

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Detailed Description

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This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.

Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Moderate hepatic

Group Type EXPERIMENTAL

TR-701 FA

Intervention Type DRUG

Oral single dose 200 mg

Severe Hepatic

Group Type EXPERIMENTAL

TR-701 FA

Intervention Type DRUG

Oral single dose 200 mg

Matched control

Group Type EXPERIMENTAL

TR-701 FA

Intervention Type DRUG

Oral single dose 200 mg

Interventions

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TR-701 FA

Oral single dose 200 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate or severe hepatic impairment or matched control
* BMI between 18.0 and 40.0 kg/m2

Exclusion Criteria

* Evidence of acute deterioration of hepatic function within 8 weeks
* ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
* Total bilirubin \> 5 mg/dl for moderates; no upper limit for severes
* Hemoglobin \< 10g/dl for moderates; Hemoglobin \< 9g/dl for severes

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes