NCT03100591已完成1 期
Single-center, Open-label Study With 14C-radiolabeled ACT-132577 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male 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
- 6
- 试验地点
- 1
- 主要终点
- Cumulative excretion of radioactivity in urine and feces
研究概览
简要总结
The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces
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 a language understandable to the subject prior to any study-mandated procedure;
- •Healthy male subjects aged between 45 and 65 years (inclusive) at screening;
- •Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
- •Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
排除标准
- •Values of hepatic aminotransferase (alanine aminotransferase and/or aspartate aminotransferase) > 3 × upper limit of normal range at screening;
- •Hemoglobin < 100 g/L at screening;
- •Known hypersensitivity to ACT-132577 or drugs of the same class, or any excipient of the ACT-132577 drug formulation;
- •Known hypersensitivity or allergy to natural rubber latex;
- •Previous exposure to ACT-132577;
- •Treatment with another investigational drug within 3 months prior to screening or participation in more than 4 investigational drug studies within 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;
- •A radiation burden of > 0.1 milliSievert (mSv) and ≤ 1.0 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2.0 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv).
研究组 & 干预措施
14C-radiolabelled ACT-132577
Experimental
On Day 1, subjects will receive a single oral dose of 25 mg 14C-radiolabeled ACT-132577, administered as an oral formulation in the fasted state
干预措施: 14C-radiolabeled ACT-132577 (Drug)
结局指标
主要结局
Cumulative excretion of radioactivity in urine and feces
时间窗: From study treatment administration up to day 15
14C-radioactivity will be measured daily in urine and feces samples for determination of total radioactivity recovery
次要结局
- Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577(From study treatment administration up to day 15)
- Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites(From study treatment administration up to day 15)
- Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577(From study treatment administration up to day 15)
- Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577(From study treatment administration up to day 15)
- Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites(From study treatment administration up to day 15)
- Time to reach Cmax (tmax) of ACT-132577 and its metabolites(From study treatment administration up to day 15)
- Terminal half-life (t1/2) of ACT-132577 and its metabolites(From study treatment administration up to day 15)
- Number of subjects with treatment-emergent adverse events and serious adverse events(From study treatment administration up to day 32)
- Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577(From study treatment administration up to day 15)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate Cenerimod in Healthy Male SubjectsHealthy SubjectsNCT02914223Viatris Innovation GmbH6
进行中（未招募）
1 期
Single Dose Study To Study The Absorption, Metabolism And Excretion Of FamitinibHealthy SubjectsNCT05473468Jiangsu HengRui Medicine Co., Ltd.6
已完成
1 期
An Open-label, Single-dose Study to Determine the Metabolism and Excretion of [14C]E2006 in Healthy Male SubjectsMetabolism and ExcretionNCT02046213Eisai Inc.16
已完成
1 期
The Absorption, Metabolism and Excretion of [14C] HQP1351 in HumansChronic Myeloid Leukemia (CML)NCT04126707Ascentage Pharma Group Inc.6
尚未招募
不适用
HPP737 Substance Balance Study in HumanPsoriasisNCT06584058Newsoara Biopharma Co., Ltd.8