A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 27 to 40 kg/m^2
- •Estimated glomerular filtration rate (eGFR) >/= 90 mL/min/1.73 m^2
- •HbA1c < 6.0% and FPG < 6.7 mol/L
排除标准
- •Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being
- •History of Type 1 or Type 2 Diabetes
- •History of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dL
- •Has medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN II) or a family history of MTC or MEN II
- •Current or past exposure to exenatide
研究组 & 干预措施
Exenatide Implant
One Exenatide Implant that delivers approximately 52 microgram/day of exenatide will be inserted subdermally just under the skin of the upper outer arm for the 9-week treatment period.
干预措施: Exenatide Implant (Combination Product)
Bydureon BCise (exenatide extended release)
2 mg subcutaneous injection every week for a duration of 9 weeks
干预措施: Bydureon BCise (exenatide extended release) (Drug)
Semaglutide
1.0 mg subcutaneous injection every week for a duration of 9 weeks
干预措施: Semaglutide, 1.0 mg/mL (Drug)
结局指标
主要结局
Adverse events
时间窗: 9 weeks
Incidence of treatment-emergent adverse events
Area under the plasma concentration-time curve (AUC)
时间窗: 9 weeks
Total exenatide concentration
Maximum plasma concentration observed (Cmax)
时间窗: 9 weeks
Maximal exenatide concentration
Time to maximum plasma concentration observed (Tmax)
时间窗: 9 weeks
Time to reach maximal exenatide concentration
次要结局
未报告次要终点