Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
Completed · Phase 1
Conditions studied: Renal Insufficiency
In brief
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
Key facts
- Study ID
- NCT02320045
- Run by
- Intarcia Therapeutics
- People needed
- 38
- Starts
- 2014-11-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2016-06-03
Who can join
Age: 25 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Intarcia Therapeutics Inc. — Boston, Massachusetts, United States
- Study Site — Kiel, Germany
- Study Site — Mannheim, Germany
- Study Site — Mönchengladbach, Germany
Full record on ClinicalTrials.gov
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