An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Percent of radioactive dose recovered in urine and feces
研究概览
简要总结
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 18 - 33 kg/m2
排除标准
- •Significant cardiovascular, pulmonary, or renal disease
研究组 & 干预措施
AKB-9778
Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1
干预措施: AKB-9778 subcutaneous injection (Drug)
结局指标
主要结局
Percent of radioactive dose recovered in urine and feces
时间窗: 7 days
Cmax of AKB-9778 and any major metabolites identified
时间窗: 7 days
Tmax of AKB-9778 and any major metabolites identified
时间窗: 7 days
Concentration of total radioactivity in blood and plasma
时间窗: 7 days
Elimination rate of AKB-9778 and any major metabolites identified
时间窗: 7 days
t1/2 of AKB-9778 and any major metabolites identified
时间窗: 7 days
AUC of AKB-9778 and any major metabolites identified
时间窗: 7 days
次要结局
- Incidence of adverse events and change in vital signs and laboratory values(7 days)