ChiCTR2300071224 版本V1.1 版本创建时间2023/06/05 16:20:21 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300071224 

最近更新日期：

Date of Last Refreshed on：

 2023-05-08 17:12:00 

注册时间：

Date of Registration：

 2023-05-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

[14C]马来酸苏特替尼在中国男性健康受试者中的物质平衡及代谢研究

Public title：

Study on substance balance and metabolism of [14C]sutertinib maleate in healthy Chinese male subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

[14C]马来酸苏特替尼在中国男性健康受试者中的物质平衡及代谢研究

Scientific title：

Study on substance balance and metabolism of [14C]sutertinib maleate in healthy Chinese male subjects

研究课题代号(代码)：

Study subject ID：

 SZCT-2022-02

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张玉强 

研究负责人：

邵凤 

Applicant：

Zhang Yuqiang 

Study leader：

Shao Feng 

申请注册联系人电话：

Applicant telephone：

 +86 15861019295

研究负责人电话：

Study leader's
telephone：

+86 13851691161

申请注册联系人传真 ：

Applicant Fax：

 +86 523 88211342

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 zhangyq@suzhongyy.com

研究负责人电子邮件：

Study leader's E-mail：

 shaofengnj@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

江苏省泰州市姜堰区苏中路1号

研究负责人通讯地址：

江苏省南京市鼓楼区广州路300号

Applicant address：

1 Suzhong Road, Jiangyan District, Taizhou City, Jiangsu

Study leader's address：

300 Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

苏中药业集团股份有限公司

Applicant's institution：

Suzhong Pharmaceutical Group Co., Ltd

研究负责人所在单位：

南京医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Nanjing Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2023-MD-012

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

南京医科大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Nanjing Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-02-28 00:00:00

伦理委员会联系人：

黄旭

Contact Name of the ethic committee：

Huang Xu

伦理委员会联系地址：

江苏省南京市鼓楼区广州路300号7号楼3楼

Contact Address of the ethic committee：

3rd Floor, Building 7, No. 300 Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 25 68306360

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

南京医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Nanjing Medical University

研究实施负责（组长）单位地址：

江苏省南京市鼓楼区广州路300号

Primary sponsor's address：

300 Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

泰州

Country：

China

Province：

Jiangsu

City：

Taizhou

单位(医院)：

苏中药业集团股份有限公司

具体地址：

姜堰区苏中路1号

Institution
hospital：

Suzhong Pharmaceutical Group Co., Ltd.

Address：

1 Suzhong Road, Jiangyan District

国家：

中国

省(直辖市)：

江苏

市(区县)：

泰州

Country：

China

Province：

Jiangsu

City：

Taizhou

单位(医院)：

江苏迈度药物研发有限公司

具体地址：

医药高新区五期

Institution
hospital：

Jiangsu Maidu Drug Research and Development Co., Ltd

Address：

Fifth Phase of the Pharmaceutical High-tech Zone

经费或物资来源：

苏中药业集团股份有限公司

Source(s) of funding：

Suzhong Pharmaceutical Group Co., Ltd.

研究疾病：

局部晚期或转移性非小细胞肺癌（NSCLC）【仅限非耐药性罕见表皮生长因子受体（EGFR）突变，包括L861Q、G719X和/或S768I】  

Target disease：

Locally advanced or metastatic non-small cell lung cancer (NSCLC) [Only non-drug-resistant rare epidermal growth factor receptor (EGFR) mutations, including L861Q, G719X and/or S768I]

研究疾病代码：

NSCLC

Target disease code：

NSCLC

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

本试验为单中心、开放、单剂量的临床药代动力学研究，旨在评价中国男性健康受试者单剂量口服80 mg/100μCi[14C]马来酸苏特替尼混悬液后体内吸收、物质平衡和生物转化途径，以揭示马来酸苏特替尼在人体内的药代动力学整体特征及安全性，为药物临床的合理使用提供参考。  

Objectives of Study：

This study is a single center, open, and single dose clinical pharmacokinetic study aimed at evaluating the absorption, material balance, and biological transformation pathways of Sutetinib Maleate suspension in healthy Chinese male subjects after a single oral dose of 80 mg/100μCi[14C]sutertinib maleate, in order to reveal the overall pharmacokinetic characteristics and safety in humans, and provide reference for the rational use of drugs in clinical practice.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄18~50周岁（包含临界值）的健康男性受试者；2.受试者体重≥50kg，且体重指数（BMI）在19.0～28.0范围内（不含上限28）；3.无重大疾病，且筛选期内体格检查、生命体征、12-导联心电图（ECG）、正位胸片及实验室检查（包括血常规、尿常规、粪便常规+隐血、血生化、凝血功能等）无异常或经临床医师判断异常无临床意义；4.具有生育能力的男性受试者，在研究开始至末次研究药物给药后6个月内禁欲或采取有效的避孕措施；5.能够与临床工作人员交流，充分了解本试验的目的并能遵照本研究的要求，在签署知情同意书上签名表明愿意参与本研究。

Inclusion criteria

1. Healthy male subjects aged 18 to 50 years (including threshold); 2. The subject's body weight is ≥ 50kg and the body mass index (BMI) is within the range of 19.0 to 28.0 (excluding the upper limit of 28); 3. There is no major disease, and there are no abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), chest radiographs, and laboratory examinations (including blood routine, urine routine, stool routine+occult blood, blood biochemistry, coagulation function, etc.) during the screening period, or the clinician determines that the abnormalities are not clinically significant; 4. Male subjects with fertility abstained or took effective contraceptive measures within 6 months from the beginning of the study to the last study drug administration; 5. Be able to communicate with clinical staff, fully understand the purpose of this study, and be able to comply with the requirements of this study. Sign on the signed informed consent form to indicate willingness to participate in this study.

排除标准：

1.存在任何经研究者判断可能会影响药物吸收、分布、代谢和排泄或可能会削弱研究方案依从性的医学状况（如心血管、肝脏、肾脏、消化道、免疫血液、内分泌、代谢、神经、精神等疾病），特别是有过吞咽困难、消化道溃疡或任何胃肠系统疾病影响药物吸收的病史；2.艾滋病病毒抗体（HIV-Ab）、丙型肝炎病毒抗体（HCV-Ab）、乙型肝炎病毒表面抗原（HBs-Ag）、梅毒螺旋体特异性抗体（TP-Ab）任意项检查结果呈阳性；3.在研究药物服药前6个月内接受过大手术（由研究者根据受试者病史判断）或受过大的创伤，或计划在研究期间进行手术；4.慢性便秘或腹泻、肠易激综合征、炎症性肠病；5.痔疮或伴有定期/正在便血的肛周疾病，或筛选/基线期大便隐血试验阳性；6.过敏体质者，如已知对两种或以上物质有过敏史；或经研究者判断可能会对试验药物活性成分或其辅料过敏；7.筛选前3个月内作为受试者参加过任何药物或医疗器械的临床试验者；8.酗酒或筛选前6个月内平均每周饮酒量超过14个单位（1个酒精单位=360 mL酒精含量为5%的啤酒或45 mL酒精含量为40%的烈酒或150 mL酒精含量为12%的葡萄酒），或酒精呼气试验阳性；9.嗜烟或筛选期前3个月内平均每日吸烟量多于5支（或使用相当量的尼古丁产品），或在试验期间无法戒断者；10.筛选期前3个月内曾有过失血或献血达400mL者，或计划在本试验结束后1个月内献血者；11.筛选前3个月内每天过量（每天8杯或以上，1杯=250mL）饮用浓茶、咖啡或含咖啡因的饮料；或在给药前48h内不能禁止代谢后产生咖啡因或含黄嘌呤的食物或饮料（如咖啡、浓茶、巧克力、可乐等）、剧烈运动；或不能遵守统一饮食；12.尿药筛查阳性者或在过去五年内有药物滥用史或筛选前3个月内使用软毒品（如：大麻、摇头丸、KEN粉、麻古等）或筛选前1年使用硬毒品（如：可卡因、海洛因、冰毒等）者；13.筛选前1个月或5个半衰期（以时间较长者为准）内使用过任何药物，包括中草药、疫苗、维生素、膳食补充剂等；14.筛选前1个月内使用过含CYP3A4强抑制剂或强诱导剂的食物，如西柚、火龙果、芒果、葡萄或含有上述水果成分的果汁等；15.筛选期前30天使用过任何抑制或诱导肝脏对药物代谢的药物（如：诱导剂，包括巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑；抑制剂，包括SSRI类抗抑郁药、西咪替丁、地尔硫卓大环内酯类、硝基咪唑类、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类）；16.静脉采血困难，不能耐受静脉穿刺，或有晕针晕血史；17.研究药物服药前发生急性疾病，例如研究药物首次服药前24 h内发生腹泻等；18.服药前1年内参加过放射性标记临床试验；19.服药前1年内有显著的放射性暴露（源于X光胸透、CT扫描或钡餐检查的放射性暴露大于1次及从事放射性相关职业）；20.研究者认为受试者存在不宜参加此试验的任何其它因素。

Exclusion criteria：

1. There are any medical conditions (such as cardiovascular, liver, kidney, digestive tract, immune blood, endocrine, metabolic, neurological, psychiatric, and other diseases) that may affect the absorption, distribution, metabolism, and excretion of the drug, or may impair the compliance with the research protocol, as judged by the researcher, especially a history of swallowing difficulties, digestive tract ulcers, or any gastrointestinal system disease that affects drug absorption; 2. AIDS virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), hepatitis B virus surface antigen (HBs Ag), treponema pallidum specific antibody (TP Ab) were positive; 3. Have undergone major surgery (as judged by the investigator based on the subject's medical history) or major trauma within 6 months before the study drug administration, or plan to undergo surgery during the study period; 4. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; 5. Hemorrhoids or perianal diseases with regular/ongoing blood in the stool, or positive stool occult blood test at screening/baseline; 6. People with allergic constitution, if known to have a history of allergies to two or more substances; Or may be allergic to the active ingredient of the test drug or its excipients according to the judgment of the researcher; 7. Those who have participated in any clinical trial of drugs or medical devices as subjects within 3 months before screening; 8. Excessive drinking or an average weekly alcohol consumption of more than 14 units (1 alcohol unit=360 mL of 5% alcohol beer, 45 mL of 40% alcohol spirits, or 150 mL of 12% alcohol wine) within the six months prior to screening, or a positive alcohol breath test; 9. Smokers or those who smoke more than 5 cigarettes (or use equivalent nicotine products) per day on average during the first 3 months of the screening period, or who are unable to quit during the trial period; 10. Those who have experienced blood loss or donated up to 400mL of blood within the first 3 months of the screening period, or who plan to donate blood within 1 month after the end of this trial; 11. Excessive consumption of strong tea, coffee, or caffeinated beverages per day (8 or more cups per day, 1 cup=250mL) for the first 3 months of screening; "Or refrain from metabolizing foods or beverages that produce caffeine or contain xanthine (such as coffee, strong tea, chocolate, cola, etc.) or strenuous exercise within 48 hours before administration;"; Or failing to follow a unified diet; 12. Those who are positive for urine drug screening or have a history of drug abuse within the past five years or have used soft drugs (such as marijuana, ecstasy, KEN powder, and ephedrine) within three months before screening or have used hard drugs (such as cocaine, heroin, and methamphetamine) within one year before screening; 13. Have used any drugs, including Chinese herbal medicines, vaccines, vitamins, dietary supplements, etc. within the first month or five half lives (whichever is longer) before screening; 14. Have used foods containing strong CYP3A4 inhibitors or strong inducers within one month before screening, such as grapefruit, pitaya, mango, grapes, or fruit juices containing the above fruit ingredients; 15. Have used any drugs that inhibit or induce liver metabolism of drugs 30 days before the screening period (such as: inducers, including barbiturates, carbamazepine, phenytoin, glucocorticoids, and omeprazole; inhibitors, including SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, and antihistamines); 16. Difficulty in venous blood collection, inability to tolerate venous puncture, or a history of needle and blood syncope; 17. Acute illness before administration of the study drug, such as diarrhea within 24 hours before the first administration of the study drug; 18. Participated in a radiolabeled clinical trial within 1 year before taking the drug; 19. Significant radiation exposure within 1 year before taking the drug (radiation exposure from chest X-ray, CT scan, or barium meal examination greater than once, and exposure to radiation related occupations); 20. The investigator believes that the subject has any other factors that are inappropriate for participation in this trial.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2024-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-15 00:00:00 至 To 2024-02-29 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 8

Group：

Test group

Sample size：

干预措施：

[14C]马来酸苏特替尼

干预措施代码：

Intervention：

[14C]sutertinib maleate

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 南京 

Country：

China

Province：

Jiangsu

City：

Nanjing

单位(医院)：

 南京医科大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Nanjing Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

全血及血浆中总放射性药动学参数

指标类型：

主要指标

Outcome：

Pharmacokinetic parameters of total radioactivity in whole blood and plasma

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药物累积排泄量

指标类型：

主要指标

Outcome：

Cumulative excretion of drugs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

原药及代谢物占比

指标类型：

主要指标

Outcome：

Proportion of technical drugs and metabolites

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血浆中非标记苏特替尼及其主要代谢产物M6-3药代动力学参数

指标类型：

次要指标

Outcome：

Pharmacokinetic parameters of unlabeled sutertinib and its main metabolite M6-3 in plasma

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

粪便

组织：

Sample Name：

Stool

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 50 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

不适用

Randomization Procedure (please state who generates the random number sequence and by what method)：

Not applicable

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

https://www.imedidata.com/

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://www.imedidata.com/

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Electronic Data Capture, EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2023-05-08 17:11:34