A PK and Safety Study in Subjects With Hepatic Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: TR-701 FA

• Registration Number: NCT01431833
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-12
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Hepatic	TR-701 FA	-
Moderate hepatic	TR-701 FA	-
Matched control	TR-701 FA	-

Primary Outcome Measures

Name	Time	Method
PK Assessment	7 days	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

Name	Time	Method
Safety	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.

Trial Locations

Locations (2)

Trius Investigator Site 001; 🇺🇸 Orlando, Florida, United States

Trius Investigator Site 002; 🇺🇸 Minneapolis, Minnesota, United States