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Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

2019年12月20日 更新者：Biogen

A Phase I, Randomized, Subject and Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.

研究概览

地位

终止

条件

干预/治疗

详细说明

A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

研究类型

介入性

注册 (实际的)

20

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

  • 新加坡
      • Singapore、新加坡、188770
        • Research Site

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

21年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
  • Total body weight >50 kilograms (kg) (110 pounds [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);
  • Positive urine drug screen;
  • Pregnant or nursing females, and females of child bearing potential;
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1
Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days.
药品：PF-04958242
按照治疗组的规定给药
实验性的：Cohort 2
Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days.
药品：PF-04958242
按照治疗组的规定给药
实验性的：Cohort 3
Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days.
药品：PF-04958242
按照治疗组的规定给药
实验性的：Cohort 4
Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days.
药品：PF-04958242
按照治疗组的规定给药
实验性的：Cohort 5
Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days.
药品：PF-04958242
按照治疗组的规定给药
实验性的：Cohort 6
Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.
药品：PF-04958242
按照治疗组的规定给药
安慰剂比较：Matching Placebo
Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days.
药品：安慰剂
按照治疗组的规定给药

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
Number of Participants Experiencing Adverse Events and Serious Adverse Events
大体时间：Baseline up to Day 23
An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Baseline up to Day 23
Maximum Plasma Drug Concentration (Cmax) for Single Dose
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Maximum Observed Plasma Concentration (Cmax) for Steady State
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Elimination Half-Life (t1/2) for Steady State
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17
Percent of Dose Eliminated in Urine Unchanged (Ae%)
大体时间：Day 14
Day 14
Amount of PF-04958242 Eliminated in Urine Unchanged (Ae)
大体时间：Day 14
Day 14
Renal Clearance (CLr)
大体时间：Day 14
Day 14
Time to Reach Maximum Plasma Concentration (Tmax) for Steady State
大体时间：Day 1 and at multiple time points up to Day 17
Day 1 and at multiple time points up to Day 17

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

Biogen

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)

2010年11月24日

初级完成 (实际的)

2011年5月3日

研究完成 (实际的)

2011年5月3日

研究注册日期

首次提交

2010年11月2日

首先提交符合 QC 标准的

2010年11月9日

首次发布 (估计)

2010年11月10日

研究记录更新

最后更新发布 (实际的)

2019年12月24日

上次提交的符合 QC 标准的更新

2019年12月20日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • B1701002

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

在美国制造并从美国出口的产品

不

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