Feasibility Study of Exenatide by Continuous Subcutaneous Infusion
- Registration Number
- NCT01857895
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This is an open-label study to investigate the feasibility of administering exenatide by continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e. Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exenatide infusion in Part A Exenatide Subjects in Part A will receive exenatide as a subcutaneous infusion at a constant rate for 24 hours. Exenatide infusion in Part B Exenatide Subjects in Part B will receive exenatide with daily increases in the infusion rate.
- Primary Outcome Measures
Name Time Method Characterization of interruptions or deviations from prescribed exenatide infusion in Part A 2 days To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
Characterization of interruptions or deviations from prescribed exenatide infusion in Part B 8 days To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
Infusion rate adjustments when nausea/vomiting occurs in Part B 8 days To investigate the feasibility of administering exenatide via continuous subcutaneous infusion. Infusion rate adjustment will be done to achieve tolerable infusion rate when nausea/vomiting occurs
Number of participants with adverse events (AEs) in Part A 17 days AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety
Number of participants with AEs in Part B 23 days AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety
Laboratory parameter assessment in Part A 17 days Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Laboratory parameter assessment in Part B 23 days Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Vital sign assessment in Part A 17 days Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
Vital sign assessment in Part B 23 days Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK) profile of exenatide in Part B 8 days PK parameters include: AUC0-24, Cmax0 to 24, and Cavg0 to 24 versus time for each of 7 days and AUC0 to 168, Cmax0 to 168, and Cavg0 to 168 versus time over entire infusion period.
Pharmacokinetic (PK) profile of exenatide in Part A PK samples will be collected at pre-dose, and at 0.5, 1, 2, 4, 6, 10, 14, 24, and 26 hours post dose. PK parameters include: area under concentration time curve from time 0 to 24 hours (AUC0 to24), maximum observed concentration from time 0 to 24 hours (Cmax0 to 24), and average concentration from time 0 to 24 hours (Cavg0 to 24) versus time
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Baltimore, Maryland, United States