An Open-Label Exploratory Study to Investigate the Feasibility of Administering Exenatide by Continuous Subcutaneous Infusion to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Characterization of interruptions or deviations from prescribed exenatide infusion in Part A
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Exenatide infusion in Part A
Subjects in Part A will receive exenatide as a subcutaneous infusion at a constant rate for 24 hours.
干预措施: Exenatide (Drug)
Exenatide infusion in Part B
Subjects in Part B will receive exenatide with daily increases in the infusion rate.
干预措施: Exenatide (Drug)
结局指标
主要结局
Characterization of interruptions or deviations from prescribed exenatide infusion in Part A
时间窗: 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
时间窗: 8 days
To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
Laboratory parameter assessment in Part A
时间窗: 17 days
Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Laboratory parameter assessment in Part B
时间窗: 23 days
Laboratory parameters include: hematology, clinical chemistry, and urinalysis
Vital sign assessment in Part A
时间窗: 17 days
Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
Vital sign assessment in Part B
时间窗: 23 days
Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
Infusion rate adjustments when nausea/vomiting occurs in Part B
时间窗: 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 AEs in Part B
时间窗: 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
Number of participants with adverse events (AEs) in Part A
时间窗: 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
次要结局
- 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.)
- Pharmacokinetic (PK) profile of exenatide in Part B(8 days)