此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations

2019年5月7日 更新者:Pfizer

A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE TABLETS COMPARED TO IMMEDIATE RELEASE TABLETS UNDER FASTED CONDITIONS

PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral doses of immediate release (IR) and modified release (MR) tablets in healthy, adult participants under fasted conditions. This is an open label, single dose, randomized, 2 period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy participants.

研究概览

研究类型

介入性

注册 (实际的)

8

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

      • Brussels、比利时、B-1070
        • Pfizer Clinical Research Unit

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 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • Healthy male, and female participants between the ages of 18 and 55 years at the time of screening, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Key Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Have or have had clinically significant infections within the past 3 months prior to the first dose of investigational product (eg, those requiring hospitalization or parenteral antibiotics, or as judged by the Investigator), evidence of any infection within the past 7 days prior to the first dose of investigational product, herpes simplex within 12 weeks or history of disseminated herpes simplex infection, symptomatic herpes zoster or recurrent (>1 episode) or disseminated herpes zoster.
  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HepBsAb) finding as a result of participant vaccination is permissible.
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON tuberculosis (TB) Gold test.
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
  • Female participants who are pregnant or wish to become pregnant; breastfeeding females.
  • Males/Females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.

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
实验性的:PF-06700841: IR followed by MR
Participants receive PF-06700841 Immediate release tablets (IR) followed by PF-06700841 Modified release tablets (MR)
Small molecule tablets in immediate release form
Small molecule tablets in modified release form
实验性的:PF-06700841: MR followed by IR
Participants receive PF-06700841 Modified release tablets (MR) followed by PF-06700841 Immediate release tablets (IR)
Small molecule tablets in immediate release form
Small molecule tablets in modified release form

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Maximum Observed Plasma Concentration (Cmax) of PF-06700841
大体时间:pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841
大体时间:pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841
大体时间:pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit
大体时间:pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose

次要结果测量

结果测量
大体时间
Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval
大体时间:Pre-dose and 48 hours post-dose
Pre-dose and 48 hours post-dose
Change from baseline in heart rate
大体时间:Pre-dose and 48 hours post-dose
Pre-dose and 48 hours post-dose
Change from baseline in blood pressure
大体时间:Pre-dose and 48 hours post-dose
Pre-dose and 48 hours post-dose
Change from baseline in pulse rate
大体时间:Pre-dose and 48 hours post-dose
Pre-dose and 48 hours post-dose
Change from baseline in oral temperature
大体时间:Pre-dose and 48 hours post-dose
Pre-dose and 48 hours post-dose
Number of participants with laboratory abnormalities
大体时间:Baseline and 48 hours post-dose
Baseline and 48 hours post-dose
Number of participants with Treatment -Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
大体时间:Baseline to 48 hours post-dose
Baseline to 48 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

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)

2019年1月7日

初级完成 (实际的)

2019年4月3日

研究完成 (实际的)

2019年4月3日

研究注册日期

首次提交

2018年11月28日

首先提交符合 QC 标准的

2018年12月4日

首次发布 (实际的)

2018年12月5日

研究记录更新

最后更新发布 (实际的)

2019年5月9日

上次提交的符合 QC 标准的更新

2019年5月7日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • B7931010
  • 2018-003512-41 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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

在美国制造并从美国出口的产品

是的

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.

PF-06700841 Immediate release tablets的临床试验

3
订阅