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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: ITCA 650 (Exenatide in osmotic mini pump)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Normal<br>Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2 | Drug: ITCA 650 (Exenatide in osmotic mini pump)<br> <br> |
| Experimental: Group 2: Mild Renal Dysfunction<br>Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2 | Drug: ITCA 650 (Exenatide in osmotic mini pump)<br> <br> |
| Experimental: Goup 3: Moderate Renal Dysfunction<br>Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2 | Drug: ITCA 650 (Exenatide in osmotic mini pump)<br> <br> |
| Experimental: Group 4: Moderate Renal Dysfunction<br>Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) >30-44 mL/min/1.73 m2 | Drug: ITCA 650 (Exenatide in osmotic mini pump)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-h Area under the Curve at steady state (AUCt,ss) |  | Approximately 67 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events |  | Approximately 67 Days | 
| Severity of adverse events |  | Approximately 67 Days | 
| Safety laboratory parameters |  | Approximately 67 Days | 
| Vital signs |  | Approximately 67 Days | 
| Electrocardiogram |  | Approximately 67 Days | 
| Physical exam |  | Approximately 67 Days |