A PK and Safety Study in Subjects With Hepatic Impairment

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Hepatic Impairment

Interventions

TR-701 FADRUG

Oral single dose 200 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Trius Investigator Site 001

Orlando, Florida, United States

Trius Investigator Site 002

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

PK Assessment

PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.

Time frame: 7 days

Secondary Outcomes

Safety

Safety Assessments evaluated through adverse events, laboratory evaluations (hematology and chemistry), vital signs, ECGs, and physical examinations, in moderate and severe hepatic impairment and matched controls.

Time frame: 7 days

Data from ClinicalTrials.gov

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