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Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects

2026年5月11日 更新者:Sunshine Lake Pharma Co., Ltd.

A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects

A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.

研究概览

研究类型

介入性

注册 (实际的)

33

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

      • Shanghai、中国
        • Shanghai Xuhui Central Hospital

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

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Subjects who are willing and are able to provide a written informed consent to participate in the study.
  • Without Plann for pregnant or sperm/egg donation plan, and voluntary effective contraceptive measures during the trial period and within 3 months after the last dose.
  • Subjects aged between 18 and 45 (both inclusive) years old.
  • The first part of the study included male and female subjects, and the second part of the study included only male subjects.
  • Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
  • Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

  • Subjects with a positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies and/or TP antibodies at screening.
  • Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or mental illness.
  • Subjects with photosensitivity and/or other skin diseases.
  • Subjects with Bleeding risk.
  • Subjects with known allergic history or constitution to peanuts, soybeans, study drugs or any of their components.
  • Take any prescription or non-prescription medications within 14 days prior to initial dosing, or take any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
  • Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
  • Positive results from urine drug screen test.
  • History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
  • For the first part of the study, subjects who had positive urine cotinine test or had smoked within 1 month before administration; for the second part of the study, subjects who had smoked more than 10 cigarettes per day within 3 months before administration.
  • Donate blood or lose blood 400 mL or more within 3 months prior to initial dosing.
  • Subjects who plan to receive or have had organ transplants.
  • Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
  • Subjects who participated in the other clinical trial within 3 months prior to initial dosing.
  • Others conditions that are not suitable for clinical trial participation.

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:非随机化
  • 介入模型:顺序分配
  • 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:HEC585 and Pirfenidone
The DDI study of HEC585 and Pirfenidone
DDI of HEC585 and Pirfenidone:HEC585, once daily,D5-D14 and D18-D27; DDI of HEC585 and Nintedanib:HEC585,once daily,D14-D23 and D27-D36
DDI of HEC583 and Pirfenidone: Pirfenidone:three times a day,D1-D3 and D25-D27
实验性的:HEC585 and Nintedanib
The DDI study of HEC585 and Nintedanib
DDI of HEC585 and Pirfenidone:HEC585, once daily,D5-D14 and D18-D27; DDI of HEC585 and Nintedanib:HEC585,once daily,D14-D23 and D27-D36
DDI of HEC585 andNintedanib:Nintedanib,twice a day,D1-D7 and D30-D36

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 curve from 0 to 24 hours [AUC (0~24)]
大体时间:Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone
Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Maximum Plasma Concentration (Cmax)
大体时间:Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585
Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase.
Area under the curve from 0 to 24 hours [AUC (0~24)]
大体时间:Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Nintedanib
Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Observed Plasma Concentration (Cmax)
大体时间:Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.
Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib
Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase.

次要结果测量

结果测量
措施说明
大体时间
Incidence of treatment-emergent adverse events (TEAEs)
大体时间:up to 31 days(HEC585 and Pirfenidone)
Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0
up to 31 days(HEC585 and Pirfenidone)
Incidence of treatment-emergent adverse events (TEAEs)
大体时间:up to 40 days(HEC585 and Nintedanib)
Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0
up to 40 days(HEC585 and Nintedanib)

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。

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6月29日

初级完成 (实际的)

2021年11月30日

研究完成 (实际的)

2021年11月30日

研究注册日期

首次提交

2022年3月29日

首先提交符合 QC 标准的

2026年5月11日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月11日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • HEC585-P-04/CRC-C2032

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

是的

研究美国 FDA 监管的设备产品

不

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