Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 25 - 80 |
| Updated: | 6/4/2016 |
| Start Date: | November 2014 |
| End Date: | July 2015 |
A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and
moderate renal impairment compared to the pharmacokinetics of subjects with normal renal
function
moderate renal impairment compared to the pharmacokinetics of subjects with normal renal
function
Inclusion Criteria:
- Body mass index between 22 and 40 kg/m²
- Subjects meeting pre-defined estimated glomerular filtration rate criteria and
creatinine clearance rate
- Normal (≥90 mL/min/1.73 m2)
- Mild (60-89 mL/min/1.73 m2)
- Moderate (45-59 mL/min/1.73 m2)
- Moderate (>30-44 mL/min/1.73 m2)
Exclusion Criteria:
- History of acute metabolic complications
- Uncontrolled Hypertension
- History of Hypersensitivity to Exenatide
- Cardiovascular Disease
- History of Acute or chronic pancreatitis
- Personal or family history of Multiple endocrine neoplasia type 2
- History of Medullary thyroid cancer
- Severe renal failure, End stage renal disease or dialysis
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