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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Exenatide

Criteria

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