A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | August 2016 |
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male
and female subjects with normal and impaired renal function. The study will be composed of
five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients)
renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their
respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
and female subjects with normal and impaired renal function. The study will be composed of
five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients)
renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their
respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
Inclusion Criteria:
-Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that
has been stable OR
- Healthy Subjects:
- Have normal renal function
- No evidence of any disease or condition that may affect pharmacokinetics of FEP-TAZ.
Exclusion Criteria:
- Evidence of hepatorenal or nephritic syndrome
- Any clinically significant abnormal findings on medical history, physical
examination,or clinical laboratory tests (other than those associated with controlled
diabetes,hypertension, hypercholesterolemia, dyslipidemia, or renal impairment or
related or causative diseases)
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