Status:
COMPLETED
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.
Detailed Description
To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with...
Eligibility Criteria
Inclusion
- BMI between 18.0 and 40.0 kg/m2 inclusive
- Male or female subjects between 18 and 75 years of age
- Stable dosage of medication for 30 days
- for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months
Exclusion
- Functioning transplanted solid organ
- High tyramine diet
- Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01452828
Start Date
October 1 2011
End Date
March 1 2012
Last Update
May 3 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