Back to resultsStudy to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ITCA 650 (Exenatide in osmotic mini pump)
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency
Eligibility 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
Sites / Locations
- Intarcia Therapeutics Inc.
- Study Site
- Study Site
- Study Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1: Normal
Group 2: Mild Renal Dysfunction
Goup 3: Moderate Renal Dysfunction
Group 4: Moderate Renal Dysfunction
Arm Description
Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2
Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) >30-44 mL/min/1.73 m2
Outcomes
Primary Outcome Measures
24-h Area under the Curve at steady state (AUCt,ss)
Secondary Outcome Measures
Rate of adverse events
Severity of adverse events
Safety laboratory parameters
Vital signs
Electrocardiogram
Physical exam
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02320045
Brief Title
Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intarcia Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Normal
Arm Type
Experimental
Arm Description
Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2
Arm Title
Group 2: Mild Renal Dysfunction
Arm Type
Experimental
Arm Description
Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2
Arm Title
Goup 3: Moderate Renal Dysfunction
Arm Type
Experimental
Arm Description
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2
Arm Title
Group 4: Moderate Renal Dysfunction
Arm Type
Experimental
Arm Description
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) >30-44 mL/min/1.73 m2
Intervention Type
Drug
Intervention Name(s)
ITCA 650 (Exenatide in osmotic mini pump)
Primary Outcome Measure Information:
Title
24-h Area under the Curve at steady state (AUCt,ss)
Time Frame
Approximately 67 Days
Secondary Outcome Measure Information:
Title
Rate of adverse events
Time Frame
Approximately 67 Days
Title
Severity of adverse events
Time Frame
Approximately 67 Days
Title
Safety laboratory parameters
Time Frame
Approximately 67 Days
Title
Vital signs
Time Frame
Approximately 67 Days
Title
Electrocardiogram
Time Frame
Approximately 67 Days
Title
Physical exam
Time Frame
Approximately 67 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Intarcia Therapeutics Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02210
Country
United States
Facility Name
Study Site
City
Kiel
Country
Germany
Facility Name
Study Site
City
Mannheim
Country
Germany
Facility Name
Study Site
City
Moenchengladbach
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
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