Status:
COMPLETED
A PK and Safety Study in Subjects With Hepatic Impairment
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 norm...
Eligibility Criteria
Inclusion
- Moderate or severe hepatic impairment or matched control
- BMI between 18.0 and 40.0 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01431833
Start Date
August 1 2011
End Date
May 1 2012
Last Update
May 20 2016
Active Locations (2)
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1
Trius Investigator Site 001
Orlando, Florida, United States, 32809
2
Trius Investigator Site 002
Minneapolis, Minnesota, United States, 55404