A PK and Safety Study in Subjects With Hepatic Impairment
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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.
Condition or disease
Drug: TR-701 FA
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.
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.
Secondary Outcome Measures
Safety [ Time Frame: 7 days ]
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.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Moderate or severe hepatic impairment or matched control
BMI between 18.0 and 40.0 kg/m2
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