Single-center, Open-label Study With 14C-radiolabeled ACT-246475 to Investigate Its Mass Balance, Pharmacokinetics, and Metabolism Following Single Subcutaneous Administration to Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Cumulative excretion of total 14C-radioactivity in urine and feces
研究概览
简要总结
The purpose of this study is to investigate how quickly and to what extent ACT-246475 is absorbed, distributed, metabolized (broken down) and eliminated from the body. ACT-246475 will be labeled with 14-Carbon (14C) and, in this way can be traced in blood, urine, and feces. This study will also investigate how safe is ACT-246475 and how well it is tolerated when administered to 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in the local language prior to any studymandated procedure,
- •Healthy male subjects aged between 45 and 65 years (inclusive) at screening,
- •No clinically significant findings on the physical examination at screening,
- •Body mass index of 18.0-28.0 kg/m2 (inclusive) at screening,
- •Systolic blood pressure (BP) 100-140 mmHg, diastolic BP 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on either arm, after 5 min in the supine position at screening,
- •12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening,
- •Values of closure time tested with the Platelet Function Analyzer equipment, for both cartridges of collagen/epinephrine and collagen/adenosine diphosphate below the upper limit of normal range at screening.
排除标准
- •Known hypersensitivity to ACT-246475 or drugs of the same class, or any excipients of the ACT-246475 formulation,
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed),
- •Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers,
- •Platelet count < 120 x10^9 L-1 at screening,
- •Previous exposure to ACT-246475,
- •Participation in another study with a radiation burden of > 0.1 mSv and ≤ 1.0 mSv in a period of 1 year prior to screening; a radiation burden of > 1 mSv and ≤ 2.0 mSv in a period of 2 years prior to screening, etc. (add 1 year per 1 mSv),
- •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 study, in the period of 1 year prior to screening,
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
研究组 & 干预措施
Treatment and observation period
On Day 1, the subjects will receive a single s.c. dose of 16 mg 14C-radiolabeled ACT-246475 in the fasted state. Subjects will be followed by an observation period of 3 days (72 h) during which blood, urine, and feces samples will be collected.
干预措施: ACT-246475 (Drug)
结局指标
主要结局
Cumulative excretion of total 14C-radioactivity in urine and feces
时间窗: Up to 54 days
Cumulative amount of total 14C-radioactivity excreted in urine and feces will be calculated by summing up the amount of total 14C-radioactivity of the samples excreted in each collection interval
次要结局
未报告次要终点