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A Study to Learn About How Different Forms of Study Medicine Prifetrastat Are Taken Up Into the Blood in Healthy Adults

2026年7月20日 更新者:Pfizer

A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 4-SEQUENCE SINGLE-DOSE CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF PRIFETRISTAT DRUG PRODUCT DIFFERING IN PARTICLE SIZE DISTRIBUTION

The purpose of this study is to understand the relative amount of drug that enters bloodstream from prifetrastat product lots differing in active ingredient particle size distribution.

The study is seeking participants who are:

Healthy males and females of non-childbearing potential >=18 years of age at screening

Participants in the study will receive a single dose of prifetrastat by mouth. After at least 14 days, they will receive another dose of prifetrastat by mouth. Each dose received by the patient will be in tablet form. The sequence in which tablets are given will be random.

The study will help understand how the difference in particle size distributions of the tablets may, or may not, affect how the drug is absorbed, processed, and eliminated by the body.

Participants will remain in the study clinic for 21 days. However, they may be permitted to leave between periods, and will have one follow-up contact.

研究概览

研究类型

介入性

注册 (估计的)

32

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

学习地点

    • Bruxelles-capitale, Région de
      • Brussels、Bruxelles-capitale, Région de、比利时、B-1070
        • 招聘中
        • Pfizer Clinical Research Unit - Brussels

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

是的

描述

Inclusion

  • Females of non-childbearing potential and males >=18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
  • BMI of 18-32 kilogram per meter square(Kg/m^2); and a total body weight >50 kg (110 lb).

Exclusion

  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
  • Prior use of epigenetic modifying agents. Participants will only be permitted to enroll in a single arm of this study (cannot participate in Arm 1 and Arm 2).
  • Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
  • current use or anticipated need for food or drugs that are known strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 2 days after the last dose of prifetrastat
  • Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.

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:基础科学
  • 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
有源比较器:Arm 1 prifetrastat
Crossover
Reference Treatment
Test 1 Treatment
有源比较器:Arm 2 prifetrastat
Crossover
Reference Treatment
Test 2 Treatment

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 Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Reference treatment of prifetrastat (AUClast If data does not permit AUCinf)
大体时间:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Maximum Observed Plasma Concentration (Cmax) profile of Reference prifetrastat treatment
大体时间:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data.
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 1 treatment of prifetrastat (AUClast If data does not permit AUCinf)
大体时间:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Maximum Observed Plasma Concentration (Cmax) profile of Test 1 prifetrastat treatment
大体时间:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data.
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 2 treatment of prifetrastat (AUClast If data does not permit AUCinf)
大体时间:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Maximum Observed Plasma Concentration (Cmax) profile of Test 2 prifetrastat treatment
大体时间:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data.
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2

次要结果测量

结果测量
大体时间
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
大体时间:Up to Day 35 after the last dose of study intervention in Period 2
Up to Day 35 after the last dose of study intervention in Period 2
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
大体时间:Up to Day 35 after the last dose of study intervention in Period 2
Up to Day 35 after the last dose of study intervention in Period 2
Number of Participants With Clinically Significant Abnormalities in Vital Signs
大体时间:Up to Day 35 after the last dose of study intervention in Period 2
Up to Day 35 after the last dose of study intervention in Period 2
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
大体时间:Up to Day 35 after the last dose of study intervention in Period 2
Up to Day 35 after the last dose of study intervention in Period 2
Number of Participants With Clinically Significant Physical Examination Abnormalities
大体时间:Up to Day 35 after the last dose of study intervention in Period 2
Up to Day 35 after the last dose of study intervention in Period 2

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

调查人员

  • 研究主任:Pfizer CT.gov Call Center、Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2026年7月14日

初级完成 (估计的)

2026年12月8日

研究完成 (估计的)

2026年12月8日

研究注册日期

首次提交

2026年7月16日

首先提交符合 QC 标准的

2026年7月20日

首次发布 (实际的)

2026年7月23日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • C4551017
  • 2026-526038-26-00 (注册表标识符:CTIS (EU))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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