A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/4/2016 |
| Start Date: | October 2011 |
| End Date: | March 2012 |
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.
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
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials