A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

A Phase I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects

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

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 normal renal function

Inclusion Criteria:

• 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 Criteria:

• 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