Renal Insufficiency
Conditions
Brief 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
Interventions
DRUGITCA 650 (Exenatide in osmotic mini pump)
Sponsors
Intarcia Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-h Area under the Curve at steady state (AUCt,ss) | Approximately 67 Days |
Secondary
| Measure | Time frame |
|---|---|
| Severity of adverse events | Approximately 67 Days |
| Safety laboratory parameters | Approximately 67 Days |
| Rate of adverse events | Approximately 67 Days |
| Electrocardiogram | Approximately 67 Days |
| Physical exam | Approximately 67 Days |
| Vital signs | Approximately 67 Days |
Countries
Germany, United States
Outcome results
None listed