A Phase 1, Open-Label, Parallel-Group, Single Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
详细描述
A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older 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
Single 900 µg dose of MBX 2109
A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen
干预措施: MBX 2109 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
时间窗: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Maximum observed concentration (Cmax)
时间窗: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC0-T)
时间窗: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Apparent clearance (CL/F) (MBX 2109 only)
时间窗: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Time to maximum concentration (Tmax)
时间窗: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Terminal elimination half-life (t1/2)
时间窗: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Apparent volume of distribution (Vz/F) (MBX 2109 only)
时间窗: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
次要结局
未报告次要终点