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Single Dose Glumetinib in Healthy Chinese Male Subjects

2022年8月17日 更新者：Haihe Biopharma Co., Ltd.

A Clinical Study to Evaluate Food Effect on Pharmacokinetics and Safety After Single Dose Glumetinib in Healthy Chinese Male Subjects

This is a phase I, single-center, randomized, open-label, single-dose, three-period (fasting, high-fat meal, low-fat meal) crossover clinical study to investigate the food effect on PK of the recommended phase II dose (RP2D) of 300 mg Glumetinib, based on the previous clinical studies of Glumetinib monotherapy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Approximately 18 healthy adult male subjects are expected to be enrolled randomly into 6 meal sequences, with 3 subjects per sequence. Each subject receive Glumetinib given under fasting condition, after a high-fat meal, or following a low-fat meal, respectively, in three periods.Subjects enrolled in each period received 300 mg Glumetinib once and PK blood samples are collected after dosing once daily for 7 days.To clarify the occurrence of AEs, subjects should complete safety examinations on Day 8 of each period. Subjects with AE are followed up before the next period of administration. Before the next administration, subjects with no AE or ongoing AE with Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 enter into the next period and continued receiving dosing; subjects reported AEs with CTCAE Grade higher than 1 are discontinued from the study and are followed up by investigator until the AE disappeared, stabilized, return to baseline or lost to follow-up (whichever occurred first)

研究类型

介入性

注册 (实际的)

18

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

  • 中国
    • Shanghai
      • Shanghai、Shanghai、中国、200020
        • Zhongshan Hositpal

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 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Subjects has to meet all of the following criteria for study entry:

    1. Healthy Chinese male subjects are 18 to 45 years of age, inclusive. "Healthy" in this criterion refers to normal results of medical history interview, physical examinations, vital sign measurements, clinical laboratory tests, chest X-ray (posteroanterior [PA]) and 12-lead electrocardiogram (ECGs), or abnormalities with no clinical significance as judged by the investigator.
    2. Bodyweight ≥50.0 kg and body mass index (BMI) are between 19.00 and 26.00 kg/m2, inclusive.

    3. Subjects should be able to take adequate and effective contraceptive measures and to avoid sperm donation during the study (from the informed consent form [ICF] signed to the last visit completed), and within 6 months after the end of the study.

      Adequate and effective contraception is defined as the following:

      • Complete abstinence: If it is consistent with subject's preference or lifestyle.

      • Adhere to the correct use of one of the following birth control measures:

        1. Use of an intra-uterine device (IUD) by the subject's female partner; or
        2. Barrier measures such as diaphragm or condom.
    4. Subjects should sign the ICF voluntarily and understand the purpose, process and risks of the study.
    5. Subjects should be able to communicate well with the investigator and comply with the requirements of the clinical study.

Exclusion Criteria:

  • Subjects who has any of the following diseases or conditions

    1. Known malignancy or psychiatric disorder.
    2. Known to suffer from acute/chronic bronchospasm (asthma, chronic obstructive pulmonary disease, etc.), pulmonary fibrosis, pulmonary tuberculosis and other diseases that affect respiratory function.
    3. Has a history of diabetes mellitus and/or pancreatitis.
    4. History of major gastrointestinal surgery (except appendicitis surgery, anal prolapse surgery), such as gastrectomy, gastroenterostomy, enterectomy, gastric bypass, gastric division or gastric banding, etc.

    5. Headache ≥2 per week and duration ≥30 minutes within 3 months, or headache episode within 1 week before administration.

      Subjects who has any of the following diseases or clinically significant abnormalities at the screening examination

    6. Suffering from allergic diseases (such as allergic rhinitis, allergic asthma), had a history of systemic allergic reactions, allergies to any component of the study drug or allergies to similar drugs
    7. Uncured pulmonitis, blood system, respiratory system, cardiovascular and cerebrovascular system, and digestive system disorders with clinical significance, and any known diseases that may affect drug absorption, distribution, metabolism and excretion.
    8. Mean corrected QT interval (QTcF) at rest > 450 ms by 12-lead ECG, or other abnormalities with clinical significance in the opinion of the investigator.

    9. Positive results for hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, treponema pallidum antibody; and non-negative for human immunodeficiency virus (HIV) antibody.

      Subjects who has any of the following conditions within a certain period before the screening/baseline (i.e., the day before the first period of administration, D-1) examination

    10. Consumed foods that affect the liver drug enzyme CYP3A4 (such as grapefruit or beverages containing grapefruit) or foods or beverages rich in xanthine (such as chocolate, coffee, red bull, etc.) within 48 hours before administration.
    11. Use any over-the-counter drugs (including vitamins and herbal supplements, etc., except vitamin-containing beverages) within one week.
    12. Use of any prescription drug within 2 weeks or less than 5 half-lives between the last prescription drug and the first dose of Glumetinib, whichever is shorter.
    13. Smoking ≥5 cigarettes per day within 3 months or unable to refrain from smoking during the study.
    14. Regular drinkers (exceeding 2 units of alcohol per day on average [1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine]) within 3 months or a positive alcohol breath test at screening/baseline.
    15. History of drug abuse within 12 months before screening examination or positive urine drug abuse screening test during the screening/baseline.
    16. Blood donation or blood loss ≥300 mL within 3 months.
    17. Participation in any other clinical studies (including clinical studies of drugs and medical devices) within 3 months.
    18. Other conditions that the investigator considered inappropriate for the subject to participate in the clinical trial.

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：卫生服务研究
  • 分配：随机化
  • 介入模型：交叉作业
  • 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：SCC244：Fasting+High-fat meal+Low-fat meal
Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition(High-fat meal) on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition （Low-fat meal）on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.
药品：Glumetinib

Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.

Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.

其他名称：
  • SCC244
实验性的：SCC244：Fasting+Low-fat meal+High-fat meal
Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition(Low-fat meal) on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition （High-fat meal）on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.
药品：Glumetinib

Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.

Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.

其他名称：
  • SCC244
实验性的：SCC244：High-fat meal+Fasting+Low-fat meal
Participants will receive a single oral dose of Glumetinib tablet in fed condition（High-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition(Low-fat meal) on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.
药品：Glumetinib

Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.

Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.

其他名称：
  • SCC244
实验性的：SCC244：High-fat meal+Low-fat meal+Fasting
Participants will receive a single oral dose of Glumetinib tablet in fed condition（High-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition（Low-fat meal） on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.
药品：Glumetinib

Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.

Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.

其他名称：
  • SCC244
实验性的：SCC244：Low-fat meal+Fasting+ High-fat meal
Participants will receive a single oral dose of Glumetinib tablet in fed condition（Low-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fed condition(High-fat meal) on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.
药品：Glumetinib

Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.

Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.

其他名称：
  • SCC244
实验性的：SCC244：Low-fat meal +High-fat meal +Fasting
Participants will receive a single oral dose of Glumetinib tablet in fed condition（Low-fat meal） on Day 1 of treatment period 1 followed by a single oral dose of Glumetinib tablet in fed condition（High-fat meal） on Day 1 of treatment period 2.Then，Participants will receive a single oral dose of Glumetinib tablet in fasting condition on Day 1 of treatment period 3. The time interval between two adjacent dosages was at least 14 days.
药品：Glumetinib

Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.

Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration.

其他名称：
  • SCC244

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
AUC0-inf
大体时间：Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose)
Area Under the Concentration-time Curve from Time zero to Infinity
Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose)
AUC0-t
大体时间：Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Area Under the Concentration-Time Curve from Time Zero to Last Measurable Time Point
Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Cmax
大体时间：Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Maximum Plasma Concentration
Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Tmax
大体时间：Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Time at Maximum Plasma Concentration (Cmax)
Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
t1/2
大体时间：Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Half-Life
Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
CL/F
大体时间：Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Apparent Clearance
Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
V/F
大体时间：Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose
Apparent Volume of Distribution
Blood samples are collected pre-dose, 0.5, 1, 2, 2.5,3, 3.5,4, 6, 8, 12, 24,36, 48, 72, 96,120, 168 hours post dose

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

Haihe Biopharma Co., Ltd.

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)

2021年3月2日

初级完成 (实际的)

2021年5月21日

研究完成 (实际的)

2021年9月30日

研究注册日期

首次提交

2022年8月17日

首先提交符合 QC 标准的

2022年8月17日

首次发布 (实际的)

2022年8月18日

研究记录更新

最后更新发布 (实际的)

2022年8月19日

上次提交的符合 QC 标准的更新

2022年8月17日

最后验证

2022年8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

  • SCC244-106

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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.

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条件

罕见疾病

药物干预

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地点

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