NCT05411146已完成1 期
A Phase 1, Open-label Study to Assess the Absorption, Metabolism, and Excretion, Including the Mass Balance, of a Single Oral Dose of [14C]-Etrumadenant in 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
- 8
- 试验地点
- 1
- 主要终点
- Mass balance recovery of total radioactivy in feces
研究概览
简要总结
This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.0 to 32.0 kg/m2
- •Body weight ≥50 kg
- •Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- •All clinical laboratory test results within the normal range or showing no clinically relevant deviations as judged by the Investigator.
- •Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from (first) admission to the clinical research center until 90 days after the study drug administration. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
排除标准
- •Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission to the clinical research center.
- •Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
- •Irregular defecation pattern (less than once per 2 days).
- •For a study with a radiation burden of superior to 0.1 mSv, the subject will be excluded if he participated in another study with a radiation burden of superior to 0.1 mSv and inferior or equal to 1 mSv in the period of 1 year prior to screening; a radiation burden of superior to 1.1 mSv and inferior or equal 2 mSv in the period of 2 years prior to screening; a radiation burden of superior to 2.1 mSv and inferior or equal 3 mSv in the period of 3 years prior to screening.
- •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.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
[14C]-etrumadenant
Experimental
Participants will receive a single dose of [14C]-etrumadenant.
干预措施: [14C]-etrumadenant (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivy in feces
时间窗: Up to 25 days
Excretion of total radioactivity in urine
时间窗: Up to 25 days
Excretion of total radioactivity in feces
时间窗: Up to 25 days
Percentage of total radioactivity in urine at selected time points
时间窗: Up to 25 days
Percentage of total radioactivity in feces at selected time points
时间窗: Up to 25 days
Mass balance recovery of total radioactivity in urine
时间窗: Up to 25 days
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 38 days
Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results
时间窗: Up to 38 days
次要结局
- Percentage of total radioactivity in plasma(Up to 24 days)
- Maximum Observed Plasma Concentration (Cmax)(Up to 25 days)
- Time to Cmax (Tmax)(Up to 25 days)
- Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last])(Up to 25 days)
- Percentage of total radioactivity in blood(Up to 24 days)
- Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf])(Up to 25 days)
- Elimination Half-life (t1/2)(Up to 25 days)
研究者
研究点 (1)
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