A PK and Safety Study in Subjects With Hepatic Impairment

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT01431833

Run by

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

People needed

32

Starts

2011-08-01

Expected to finish

2012-05-01

Last updated by the study team

2016-05-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify 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

Where it is running

• Trius Investigator Site 001 — Orlando, Florida, United States
• Trius Investigator Site 002 — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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