ChiCTR2200065124 版本V1.1 版本创建时间2023/04/28 10:54:34 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：

 ChiCTR2200065124 

最近更新日期：

Date of Last Refreshed on：

 2022-10-28 16:24:49 

注册时间：

Date of Registration：

 2022-10-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

伊曲康唑胶囊对HS-10352片在健康受试者中单中心、开放、 单剂量、自身对照的药代动力学影响研究

Public title：

Itraconazole capsules on HS-10352 tablets in healthy subjects in a single-centre, open, single-dose, self-controlled single-dose, self-controlled pharmacokinetic effect study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

伊曲康唑胶囊对HS-10352片在健康受试者中单中心、开放、 单剂量、自身对照的药代动力学影响研究

Scientific title：

Itraconazole capsules on HS-10352 tablets in healthy subjects in a single-centre, open, single-dose, self-controlled single-dose, self-controlled pharmacokinetic effect study

研究课题代号(代码)：

Study subject ID：

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：

黄欣 

研究负责人：

阳国平/项玉霞 

Applicant：

Xin Huang 

Study leader：

Guoping Yang/Yuxia Xiang 

申请注册联系人电话：

Applicant telephone：

 13481766459

研究负责人电话：

Study leader's
telephone：

0731-89918665

申请注册联系人传真 ：

Applicant Fax：

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：

 xinhuang8686@126.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@126.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：

湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

Study leader's address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan 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：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验研究中心

Affiliation of the Leader：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South 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：

 22070

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

IRB, the Third Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-06-23 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin WANG

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号中南大学湘雅三医院伦理委员会

Contact Address of the ethic committee：

IRB, the Third Xiangya Hospital, Central South University, 138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

中南大学湘雅三医院临床试验研究中心

Primary sponsor：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Changsha

City：

Changsha

单位(医院)：

中南大学湘雅三医院临床试验研究中心

具体地址：

湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

Address：

138 Tongzibo Road, Yuelu District, Changsha, Hunan

经费或物资来源：

上海翰森生物医药科技有限公司

Source(s) of funding：

Shanghai Hansen Biomedical Technology Co.

研究疾病：

乳腺癌  

Target disease：

Breast cancer

研究疾病代码：

Target disease code：

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：

主要目的：评价伊曲康唑胶囊对HS-10352片药代动力学的影响。 次要目的：评价健康受试者单次口服HS-10352片以及与伊曲康唑胶囊联合用药后的安全性。  

Objectives of Study：

Primary objective: To evaluate the effect of itraconazole capsules on the pharmacokinetics of HS-10352 tablets. Secondary objective: To evaluate the safety of HS-10352 Tablets in healthy subjects following a single oral dose and in combination with Itraconazole Capsules.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

受试者必须符合下列所有标准才能入选：
1)年龄在18~45周岁之间（包含边界值），男女均可；
2)男性受试者的体重≥50.0 kg，女性受试者的体重≥45.0 kg，体重指数（BMI）在19 ~ 26 kg/m2之间，含临界值；
3)受试者自愿签署书面的知情同意书。

Inclusion criteria

To be enrolled, subjects must meet all of the following criteria.
1) Age between 18 ~ 45 years (including cut-off values), both sexes.
2) Male subjects weighing ≥ 50.0 kg and female subjects weighing ≥ 45.0 kg with a body mass index (BMI) between 19 ~ 26 kg/m2, including cut-off values.
3) Subjects voluntarily sign a written informed consent form.

排除标准：

符合一条或多条下列标准的受试者将被排除：
1)生命体征异常者（收缩压<90 mmHg或>140 mmHg，舒张压<50 mmHg或>90 mmHg；心率<50 bpm或>100 bpm）或体格检查、心电图、实验室检查【肝功能（ALT、AST、总胆红素）大于1×ULN】异常有临床意义（以临床研究医生判断为准）；
2)既往或目前正患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、泌尿生殖系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病者或能干扰试验结果的任何其他疾病；
3)患有任何增加血糖升高风险的疾病者，如既往有原发性糖尿病病史、妊娠期糖尿病病史、类固醇诱导糖尿病病史或其他继发性糖尿病病史者，患有急性或慢性胰腺炎者；
4)存在可能增加QTc延长风险或心律失常事件风险的各种因素，如既往患有器质性心脏病史、心力衰竭史、心肌梗死史、心绞痛史、心律失常史、扭转性室速史、室性心动过速史、房室传导阻滞、QT延长综合征史、12导联心电图中Fridericia法校正的QT间期（QTcF）≥470 msec（女）/450 msec（男）或临床医生判定有其它临床意义的异常者；
5)试验前4周内接受过外科手术，或计划在研究期间进行外科手术者；
6)接受过会影响药物吸收、分布、代谢、排泄的手术，经研究者判断不适合入组者；
7)有吞咽困难或任何影响药物吸收的胃肠道疾病史，经研究者判断不适合入组者；
8)有药物、食物或其他物质过敏史；
9)试验前14天内服用过任何药物或保健品者（包括中草药）；
10)试验前30天内使用过任何抑制或诱导肝脏对药物代谢的药物（如：CYP3A4诱导剂卡马西平、地塞米松、利福平、苯妥英、苯巴比妥、贯叶连翘等；CYP3A4抑制剂伊曲康唑、酮康唑、克拉霉素、泰利霉素、洛匹那韦、利托那韦等；CYP2C8诱导剂利福平；CYP2C8抑制剂吉非罗齐、氯吡格雷、地拉罗司、特立氟胺等）者；
11)试验前3个月内参加任何临床试验且服用了任何临床试验药物者；
12)在入选前3个月内献血或大量失血（≥200 mL，不包括女性月经期失血）、接受输血或使用血制品者；
13)对饮食有特殊要求，不能遵守统一饮食者；
14)每天饮用过量茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250 mL）者；
15)嗜烟者或试验前3个月每日吸烟量多于5支者或试验期间不能停止使用任何烟草类产品者
16)酗酒者或试验前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）或试验期间不能停止使用任何含酒精产品者；
17)在服用研究用药前24h内，服用过任何含酒精的制品，或酒精呼气检查阳性者；
18)药物滥用者或试验前3个月使用过软毒品（如：大麻）或试验前1年服用硬毒品（如：可卡因、苯环己哌啶等）者；
19)在研究前筛选阶段或研究用药前新发疾病者；
20)不能耐受静脉穿刺采血，或有晕针、晕血史者；
21)妊娠或哺乳期妇女，以及受试者及其配偶从签署知情同意书至最后一次给药后3个月内有生育、或捐精、或捐卵计划，或无法保证在此期间采用有效避孕措施（试验期间采取一种或一种以上非药物避孕措施）者；
22)筛选前1个月内接受过灭活疫苗接种，筛选前3个月内接受过活/减毒疫苗接种或计划在试验期间接受灭/活/减毒疫苗接种者；
受试者可能因为其他原因而不能完成本研究或研究者认为不应纳入者。

Exclusion criteria：

Subjects meeting one or more of the following criteria will be excluded.
1) Those with abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; heart rate <50 bpm or >100 bpm) or abnormal physical examination, electrocardiogram, laboratory tests [liver function (ALT, AST, total bilirubin) >1 x ULN] of clinical significance (as judged by the clinical investigator).
2) Persons with any previous or current clinically serious disease of the circulatory, endocrine, neurological, digestive, respiratory, genitourinary, haematological, immunological, psychiatric and metabolic abnormalities or any other disease that can interfere with the test results.
3) Persons with any condition that increases the risk of elevated blood glucose, such as a previous history of primary diabetes, gestational diabetes, steroid-induced diabetes or other secondary diabetes, with acute or chronic pancreatitis.
4) The presence of factors that may increase the risk of QTc prolongation or arrhythmic events, such as previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, arrhythmia, torsional ventricular tachycardia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, 12-lead ECG with a Fridericia method-corrected QT interval (QTcF) ≥ 470 msec (female)/450 msec (male) or any other clinically significant abnormality as determined by the clinician.
5) who have undergone surgical procedures within 4 weeks prior to the trial, or who are scheduled to undergo surgical procedures during the study period
6)those who have undergone surgery that would interfere with the absorption, distribution, metabolism, or excretion of the drug and who, in the judgment of the investigator, are unsuitable for enrollment
7) who have a history of dysphagia or any gastrointestinal disorder that would interfere with drug absorption and who, in the judgment of the investigator, are unsuitable for enrollment
8)a history of allergy to drugs, food or other substances
9)those who have taken any medication or health product (including herbal medicines) within 14 days prior to the trial
10) have used any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to the trial (e.g. CYP3A4 inducer carbamazepine, dexamethasone, rifampicin, phenytoin, phenobarbital, and onychomycin; CYP3A4 inhibitors itraconazole, ketoconazole, clarithromycin, telithromycin, lopinavir, ritonavir, etc.; CYP2C8 inducer rifampicin; CYP2C8 inhibitors (gefirozil, clopidogrel, deferasirox, teriflunomide, etc.).
11) Those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial
12) Those who have donated blood or lost a significant amount of blood (≥ 200 mL, excluding blood loss during menstruation in women), received a blood transfusion or used blood products within the 3 months prior to enrollment.
13) persons with special dietary requirements who are unable to comply with a uniform diet
14) those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day
15)smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or those who were unable to stop using any tobacco-based products during the trial
16) heavy drinkers or regular drinkers of alcohol in the 6 months prior to the trial, i.e. more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine) or unable to stop using any alcohol-containing product during the trial
17) who have taken any alcohol-containing product within 24 h prior to taking the study drug or who have a positive breath test for alcohol
18) drug abusers or those who have used soft drugs (e.g. cannabis) in the 3 months prior to the trial or hard drugs (e.g. cocaine, phencyclidine, etc.) in the 1 year prior to the trial
19)persons with a new onset of disease during the pre-study screening phase or prior to study drug administration
20) Those who cannot tolerate venipuncture blood collection, or have a history of needle or blood sickness
21) pregnant or lactating women, and subjects and their spouses who are planning to give birth, or donate sperm or eggs within 3 months from the signing of the informed consent to the last dose, or who are unable to ensure the use of effective contraception (one or more non-pharmaceutical contraceptive measures during the trial) during this period
22) who have received inactivated vaccination within 1 month prior to screening, live/attenuated vaccination within 3 months prior to screening or who plan to receive inactivated/live/attenuated vaccination during the trial
Subjects who may not be able to complete this study for other reasons or who, in the opinion of the investigator, should not be included.

研究实施时间：

Study execute time：

从 From 2022-10-31 00:00:00至 To 2025-10-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-10-29 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 20

Group：

A

Sample size：

干预措施：

20名健康者在D1单次空腹口服HS-10352片6mg，D5-D7早餐后立即口服伊曲康唑胶囊200mg，每日一次，D8空腹服用伊曲康唑胶囊200mg，间隔1小时后服用HS-10352片6mg，D9-D12口服伊曲康唑胶囊200mg，每日一次。

干预措施代码：

Intervention：

Twenty healthy individuals received HS-10352 tablets 6mg orally on a single empty stomach in D1, itraconazole capsules 200mg orally once daily immediately after breakfast in D5-D7, itraconazole capsules 200mg on an empty stomach with an interval of 1 hour in D8 and HS-10352 tablets 6mg orally once daily in&

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三甲 

Institution
hospital：

The Third Xiangya Hospital of Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血药浓度

指标类型：

主要指标

Outcome：

Blood concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体格检查

指标类型：

主要指标

Outcome：

Physical examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

Vital signs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

糖代谢相关指标

指标类型：

主要指标

Outcome：

Glucose metabolism-related indicators

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

12导联ECG

指标类型：

主要指标

Outcome：

12-lead ECG

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

主要指标

Outcome：

Adverse events

Type：

Primary 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：

血样

组织：

Sample Name：

Blood sample

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：

尿样

组织：

Sample Name：

Urine sample

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 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

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)：

N/A

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）：

未说明（请阅读网站首页注册指南共享原始数据的方式内容）

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

Not stated

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：

本次试验采用电子化数据管理，使用电子数据采集系统（DAS for EDC V6.0或以上版本）。电子病例报告表（eCRF）：数据管理员根据试验方案设计构建，并根据数据核查计划（DVP）设置逻辑核查，通过测试并获申办方批准后发布使用。 数据录入：eCRF数据来源于原始记录，由数据录入人员根据eCRF填写说明，将志愿者访视数据及时录入 EDC。

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

This experiment adopts electronic data management and uses electronic data acquisition system (DAS for EDC V6.0 or above). Electronic case report form (eCRF): The data administrator builds according to the design of the trial protocol, and sets up logical verification according to the data verification plan (DVP), which is released for use after passing the test and being approved by the sponsor. Data entry: The eCRF data comes from the original records, and the data entry personnel fill in the instructions according to the eCRF,and enter the volunteer visit data into the EDC in time.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-10-28 16:24:41