A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Oxazolidinones; Tedizolid; Tedizolid phosphate; Torezolid; Torezolid phosphate

Criteria

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