NCT04182958已完成1 期
A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form
研究概览
简要总结
- To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815.
- To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815
- To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815
- To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815
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
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese passport and be first generation Japanese, defined as the subject, the subject's biological parent, and all of the subject's biological grandparents being of exclusive Japanese descent, have been born in Japan, and not lived outside of Japan for more than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive; in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations at Screening and Check in as assessed by the investigator (or designee); and have a history of a minimum of 1 bowel movement per day.
排除标准
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion; poor peripheral venous access; participation in a clinical trial involving administration of an investigational drug in the past 90 days prior to dosing; subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; subjects who have participated in any clinical trial involving a radiolabeled investigational drug within 12 months prior to Check-in.
研究组 & 干预措施
(14C)-OPC-61815
Experimental
干预措施: (14C)-OPC-61815 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form
时间窗: 48 hours after dose
Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form
时间窗: 48 hours after dose
Cmax - Plasma OPC-41061
时间窗: 48 hours after dose
t1/2,z - Plasma OPC-41061
时间窗: 48 hours after dose
AUC∞ - Plasma Total Radioactivity
时间窗: 168 hours after dose
Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form
时间窗: 48 hours after dose
AUC∞ - Plasma OPC-41061
时间窗: 48 hours after dose
t1/2,z - Plasma Total Radioactivity
时间窗: 168 hours after dose
Cmax - Plasma Total Radioactivity
时间窗: 168 hours after dose
次要结局
未报告次要终点
研究者
研究点 (1)
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