A PK and Safety Study in Subjects With Hepatic Impairment

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

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: TR-701 FA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431833

1986-001

TR701-124 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 3 patient groups

Moderate hepatic

Experimental group

Treatment:

Drug: TR-701 FA

Severe Hepatic

Experimental group

Treatment:

Drug: TR-701 FA

Matched control

Experimental group

Treatment:

Drug: TR-701 FA