A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
2018年11月28日 更新者：Cascadian Therapeutics Inc.
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
8
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53704
- Covance Clinical Research Unit
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tucatinib
|
Single dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
大体时间：Up to 14 days
|
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
|
Up to 14 days
|
|
AUC from time 0 to last quantifiable concentration
大体时间：Up to 14 days
|
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
|
Up to 14 days
|
|
Maximum observed concentration
大体时间：Up to 14 days
|
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
|
Up to 14 days
|
|
Time of maximum observed concentration
大体时间：Up to 14 days
|
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
|
Up to 14 days
|
|
Apparent terminal elimination half-life
大体时间：Up to 14 days
|
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
|
Up to 14 days
|
|
Apparent total clearance
大体时间：Up to 14 days
|
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
|
Up to 14 days
|
|
Apparent volume of distribution
大体时间：Up to 14 days
|
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
|
Up to 14 days
|
|
AUC[0-inf] plasma tucatinib/total radioactivity ratio
大体时间：Up to 14 days
|
AUC[0-inf] of plasma tucatinib relative to AUC[0-inf] of plasma total radioactivity
|
Up to 14 days
|
|
AUC[0-inf] blood/plasma ratio
大体时间：Up to 14 days
|
AUC[0-inf] of whole blood total radioactivity to AUC[0-inf] of plasma total radioactivity
|
Up to 14 days
|
|
Amount excreted in urine (Aeu)
大体时间：Up to 14 days
|
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
|
Up to 14 days
|
|
Cumulative Aeu
大体时间：Up to 14 days
|
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
|
Up to 14 days
|
|
Percentage excreted in urine (Feu)
大体时间：Up to 14 days
|
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
|
Up to 14 days
|
|
Cumulative Feu
大体时间：Up 14 days
|
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
|
Up 14 days
|
|
Renal clearance
大体时间：Up to 14 days
|
PK outcome endpoint of tucatinib derived from urine collections
|
Up to 14 days
|
|
Amount excreted in feces [Aef]
大体时间：Up to 14 days
|
PK outcome endpoint of total radioactivity derived from feces collection
|
Up to 14 days
|
|
Cumulative Aef
大体时间：Up to 14 days
|
PK outcome endpoint of total radioactivity derived from feces collection
|
Up to 14 days
|
|
Percentage excreted in feces [Fef]
大体时间：Up to 14 days
|
PK outcome endpoint of total radioactivity derived from feces collection
|
Up to 14 days
|
|
Cumulative Fef
大体时间：Up to 14 days
|
PK outcome endpoint of total radioactivity derived from feces collection
|
Up to 14 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Relative abundance of tucatinib and its metabolites eliminated in urine and feces
大体时间：Up to 14 days
|
Up to 14 days
|
|
Relative abundance of tucatinib and its metabolites in plasma
大体时间：Up to 14 days
|
Up to 14 days
|
|
Incidence of adverse events (AEs)
大体时间：Up to 14 days
|
Up to 14 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Alex Vo, PhD、Cascadian Therapeutics Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年12月30日
初级完成 (实际的)
2018年1月30日
研究完成 (实际的)
2018年1月30日
研究注册日期
首次提交
2018年11月13日
首先提交符合 QC 标准的
2018年11月28日
首次发布 (实际的)
2018年11月29日
研究记录更新
最后更新发布 (实际的)
2018年11月29日
上次提交的符合 QC 标准的更新
2018年11月28日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
tucatinib的临床试验
-
Institut CuriePfizer; UNICANCER; Eurofins招聘中
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iOMEDICO AGSeagen Germany GmbH (a Pfizer company)完全的
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Pfizer主动，不招人
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Memorial Sloan Kettering Cancer CenterPfizer; Seagen Inc.主动，不招人
-
Pfizer完全的
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OnKure, Inc.招聘中
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Memorial Sloan Kettering Cancer Center招聘中
-
Seagen, a wholly owned subsidiary of Pfizer完全的
-
Seagen, a wholly owned subsidiary of PfizerRemeGen Co., Ltd.招聘中胃肿瘤 | 乳腺肿瘤 | 晚期乳腺癌 | 转移性乳腺癌 | 三阴性乳腺肿瘤 | 转移性胃癌 | 胃食管结合部腺癌 | 晚期胃癌 | HER2阳性乳腺肿瘤 | HER2 低位乳腺肿瘤美国, 英国, 西班牙, 加拿大, 台湾, 德国, 澳大利亚, 日本, 意大利, 韩国