A PK and Safety Study in Subjects With Hepatic Impairment

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Tedizolid phosphate; Torezolid phosphate

Criteria

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