A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.

Key facts

Study ID

NCT01452828

Run by

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

People needed

24

Starts

2011-10-01

Expected to finish

2012-03-01

Last updated by the study team

2016-05-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trius Investigator Site 001 — Orlando, Florida, United States
• Trius Investigator Site 002 — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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