A Phase 1 Open-Label Mass Balance Clinical Trial to Investigate the Absorption, Metabolism, and Excretion of Single Oral Administration of [14C]-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
Mass balance clinical trial with TEV-56286
详细描述
Primary objectives:
- To investigate the mass balance and excretion of TEV-56286 following a single oral dose of [14C]-TEV-56286
- To assess the pharmacokinetics following a single oral dose of [14C]-TEV-56286
Secondary objective:
- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration
The total duration of the clinical trial for each participant is expected to be approximately 59 days.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of the study drug, or surgery scheduled during the clinical trial including the follow-up period.
- •No history of malignancy or treatment of malignancy in the last 5 years.
- •No personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope of undetermined reason or previous treatment for high blood pressure.
- •NOTE- Additional criteria apply, please contact the investigator for more information
排除标准
- •History of relevant drug and/or food allergies.
- •Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical trial in the period of 1 year prior to screening.
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
TEV-56286
干预措施: [14C]-TEV-56286 (Drug)
TEV-56286
干预措施: TEV-56286 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to Day 22
Cumulative Amount of Total Radioactivity (TRA)
时间窗: Up to Day 22
Cumulative Percent of TRA From the Total Radioactive Dose Administered
时间窗: Up to Day 22
Time to Attain Maximum Observed Plasma Concentration (Tmax)
时间窗: Up to Day 22
Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24)
时间窗: Up to Day 22
Area Under the Plasma Concentration-time Curve Up To Time t, Where t is the Last Point with Concentrations Above the Lower Limit of Quantification (AUC0-t)
时间窗: Up to Day 22
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
时间窗: Up to Day 22
Terminal elimination half-life (t1/2)
时间窗: Up to Day 22
次要结局
- Number of Participants With At Least One Treatment-Emergent Adverse Event(Up to Day 59)
- Number of Participants Who Did Not Complete the Trial Due to an Adverse Event(Up to Day 59)