Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
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
1 other identifier
interventional
38
2 countries
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2014
Shorter than P25 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJune 3, 2016
June 1, 2016
8 months
November 26, 2014
June 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
24-h Area under the Curve at steady state (AUCt,ss)
Approximately 67 Days
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
Group 1: Normal
EXPERIMENTALNormal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2
Group 2: Mild Renal Dysfunction
EXPERIMENTALSubjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2
Goup 3: Moderate Renal Dysfunction
EXPERIMENTALSubjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2
Group 4: Moderate Renal Dysfunction
EXPERIMENTALSubjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) \>30-44 mL/min/1.73 m2
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Intarcia Therapeutics Inc.
Boston, Massachusetts, 02210, United States
Study Site
Kiel, Germany
Study Site
Mannheim, Germany
Study Site
Mönchengladbach, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2014
First Posted
December 19, 2014
Study Start
November 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
June 3, 2016
Record last verified: 2016-06