Human ADME Study of [14C]-AZD1390
2026年6月10日 更新者：AstraZeneca
A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies
This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.
研究概览
详细说明
On Day 1, participants will receive one dose of [14C]-AZD1390 . Participants will be confined to the study site until Day 8.
Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.
Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.
研究类型
介入性
注册 (估计的)
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。
学习联系方式
- 姓名：AstraZeneca Clinical Study Information Center
- 电话号码：1-877-240-9479
- 邮箱：information.center@astrazeneca.com
学习地点
-
-
-
Guildford、英国、GU2 7WG
- Research Site
-
Liverpool、英国、L7 8XP
- Research Site
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,
- Predicted life expectancy ≥ 12 weeks,
- Adequate organ and marrow function,
- Creatinine clearance ≥ 50 mL/min,
- Regular bowel movements,
- No cancer-associated cachexia (weight loss).
Exclusion Criteria:
- History or presence of myopathy or raised CK > 5 × ULN at screening,
- History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,
- History or presence of clinically significant hepatic disease,
- History of epileptic disorder or any seizure history unrelated to tumour,
- History of MDS/AML or with features suggestive of MDS/AML,
- Predisposition to bleeding
- History of persisting (> 2 weeks) severe cytopenia
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection
- History of another primary malignancy
- Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,
- Spinal cord compression or brain metastases for at least 4 weeks
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：AZD1390
Single dose of [14C]-AZD1390
|
single dose
|
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 |
|---|---|---|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Amount excreted (Ae) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Cumulative Amount excreted (CumAe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Amount excreted (Ae) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Cumulative Amount excreted (CumAe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Amount excreted (Ae) (total - urine and feaces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Cumulative Amount excreted (CumAe) (total urine and feaces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Amount (percentage) excreted (Fe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Cumulative Amount (percentage) excreted (CumFe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Amount (percentage) excreted (Fe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Cumulative Amount (percentage) excreted (CumAe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Amount (percentage) excreted (Fe) (total urine and faeces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
大体时间：6 Weeks
|
If emesis occurs, vomitus will be analysed for total radioactivity
|
6 Weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Maximum observed concentration (Cmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis whole blood: Maximum observed concentration (Cmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
大体时间：6 weeks
|
Analysis of urine: Cumulative amount excreted (CumAe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
大体时间：6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
The distribution of total radioactivity into blood cells after a single oral dose
大体时间：6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
大体时间：6 weeks
|
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
大体时间：6 weeks
|
Analysis of urine: Renal clearance (CLR)
|
6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Maximum observed concentration (Cmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
大体时间：6 weeks
|
Analysis of metabolite in plasma: parent ratio
|
6 weeks
|
|
Metabolic profiling following single oral dose of AZD1390
大体时间：6 weeks
|
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
|
6 weeks
|
|
The safety of a single dose of AZD1390
大体时间：6 weeks
|
Number of participants with AEs and SAEs and severity of AEs and SAEs (based on CTCAE v5).
|
6 weeks
|
|
The safety of a single dose of AZD1390
大体时间：6 weeks
|
Number of participants with laboratory abnormalities based on assessment of Haematology/Haemostasis (whole blood), Urinalysis (dipstick), Serology, Clinical chemistry (serum or plasma), Creatinine clearance.
|
6 weeks
|
|
The safety of a single dose of AZD1390
大体时间：6 weeks
|
Number of participants with abnormal ECG and measurement of heart rate, PR QRS, QT and QTcF intervals (in milliseconds)
|
6 weeks
|
|
The safety of a single dose of AZD1390
大体时间：6 weeks
|
Number of participants with abnormal vital signs based on assessment of body temperature, pulse rate, and blood pressure completed with automated devices.
|
6 weeks
|
|
The safety of a single dose of AZD1390
大体时间：6 weeks
|
Assessment of weight (measurement units can be variable) throughout the study.
|
6 weeks
|
|
The safety of a single dose of AZD1390
大体时间：6 weeks
|
Number of participants with abnormal physical examination based on assessment of general appearance, respiratory, cardiovascular, abdomen, skin, head and neck, lymph nodes, thyroid, musculoskeletal, and neurological systems.
|
6 weeks
|
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。
赞助
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 (估计的)
2026年6月30日
初级完成 (估计的)
2028年4月12日
研究完成 (估计的)
2028年4月12日
研究注册日期
首次提交
2025年12月18日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月12日
研究记录更新
最后更新发布 (实际的)
2026年6月12日
上次提交的符合 QC 标准的更新
2026年6月10日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- D6940C00006
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共享时间框架
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享访问标准
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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.