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Lead
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Moderate or severe hepatic impairment or matched control
BMI between 18.0 and 40.0 kg/m2
You may not be if
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
Clareo Health | A PK and Safety Study in Subjects With Hepatic Impairment
