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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion.
GSK Investigational Site
Baltimore, Maryland, United States
Characterization of interruptions or deviations from prescribed exenatide infusion in Part A
To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
Time frame: 2 days
Characterization of interruptions or deviations from prescribed exenatide infusion in Part B
To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
Time frame: 8 days
Infusion rate adjustments when nausea/vomiting occurs in Part B
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
Time frame: 8 days
Number of participants with adverse events (AEs) in Part A
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
Time frame: 17 days
Number of participants with AEs in Part B
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
Time frame: 23 days
Laboratory parameter assessment in Part A
Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Time frame: 17 days
Laboratory parameter assessment in Part B
Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Time frame: 23 days
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Vital sign assessment in Part A
Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
Time frame: 17 days
Vital sign assessment in Part B
Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
Time frame: 23 days
Pharmacokinetic (PK) profile of exenatide in Part A
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
Time frame: PK samples will be collected at pre-dose, and at 0.5, 1, 2, 4, 6, 10, 14, 24, and 26 hours post dose.
Pharmacokinetic (PK) profile of exenatide in Part B
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.
Time frame: 8 days