A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [¹⁴C]-Tucatinib Following a Single Oral Dose in Healthy Male and Female Subjects
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
- Apparent total clearance
研究概览
简要总结
This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib while it is still in the body. Healthy participants will get one dose of tucatinib by mouth. Patients will be monitored for 8-14 days after they take the dose of tucatinib.
详细描述
This study will examine the absorption, metabolism, and excretion of tucatinib in healthy individuals. Participants will receive one oral dose of tucatinib and will be followed for 8-14 days after the dose is received.
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
- All
- 接受健康志愿者
- 是
入选标准
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, or lab evaluations
- •Body mass index (BMI) between 18 and 32 kg/m²
- •Weight between 50 and 100 kg
- •Females must be of non-childbearing potential
- •Males must agree to use contraception
排除标准
- •History of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- •Any condition affecting drug absorption
- •History of hypersensitivity or allergy to any drug compound, food, or other substance
- •History of alcoholism or drug/chemical abuse within 2 years
- •Use of prescription products within 28 days prior to check in
- •Use of tobacco- or nicotine-containing products within 3 months prior to check in
研究组 & 干预措施
Tucatinib
干预措施: tucatinib (Drug)
结局指标
主要结局
Apparent total clearance
时间窗: Up to 14 days
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
Maximum observed concentration
时间窗: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
时间窗: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Time of maximum observed concentration
时间窗: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Apparent terminal elimination half-life
时间窗: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
AUC from time 0 to last quantifiable concentration
时间窗: Up to 14 days
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Apparent volume of distribution
时间窗: Up to 14 days
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
AUC[0-inf] plasma tucatinib/total radioactivity ratio
时间窗: Up to 14 days
AUC\[0-inf\] of plasma tucatinib relative to AUC\[0-inf\] of plasma total radioactivity
AUC[0-inf] blood/plasma ratio
时间窗: Up to 14 days
AUC\[0-inf\] of whole blood total radioactivity to AUC\[0-inf\] of plasma total radioactivity
Amount excreted in urine (Aeu)
时间窗: Up to 14 days
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Cumulative Aeu
时间窗: Up to 14 days
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Percentage excreted in urine (Feu)
时间窗: Up to 14 days
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Cumulative Feu
时间窗: Up 14 days
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Renal clearance
时间窗: Up to 14 days
PK outcome endpoint of tucatinib derived from urine collections
Amount excreted in feces [Aef]
时间窗: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
Cumulative Aef
时间窗: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
Percentage excreted in feces [Fef]
时间窗: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
Cumulative Fef
时间窗: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
次要结局
- Relative abundance of tucatinib and its metabolites eliminated in urine and feces(Up to 14 days)
- Relative abundance of tucatinib and its metabolites in plasma(Up to 14 days)
- Incidence of adverse events (AEs)(Up to 14 days)