Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects

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

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