A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
2018年6月18日 更新者：Pfizer
A Phase 1, Single-dose, Randomized, 4-treatment, 4-period Crossover, Placebo- And Positive-controlled, Double-blind (Open-label For Positive Control), Sponsor-open Study To Determine The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects.
This is conducted as part of standard drug development.
研究概览
研究类型
介入性
注册 (实际的)
44
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
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Connecticut
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New Haven、Connecticut、美国、06511
- Pfizer New Haven Clinical Research Unit
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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
Inclusion Criteria:
- Healthy female subjects of non childbearing potential and/or healthy male subjects, between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
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 the time of dosing).
- History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic brain injury.
- History of seizures or history or physical examination findings (eg localizing signs on neurologic examination) suggestive of structural central nervous system (CNS) abnormalities which may place patient at increased risk of seizures.
- History of orthostatic blood pressure changes or clinically significant orthostatic symptoms.
- Self reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PF-04447943 low dose
25 mg of PF-04447943
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Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
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实验性的：PF-04447943 high dose
100 mg of PF-04447943
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Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
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安慰剂比较：Placebo
Matching placebo for PF-04447943
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Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
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有源比较器：Moxifloxacin
400 mg of moxifloxacin
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Single oral dose of moxifloxacin administered as tablet
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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 |
|---|---|---|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose
大体时间：0.5 hour post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5 hour post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
大体时间：1 hour post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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1 hour post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
大体时间：2 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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2 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
大体时间：3 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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3 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
大体时间：4 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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4 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
大体时间：8 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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8 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
大体时间：12 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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12 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
大体时间：24 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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24 hours post-dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
大体时间：0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.
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0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
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Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
大体时间：0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
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Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
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Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
大体时间：0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
大体时间：0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.
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Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
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Number of Participants With Physical Examination Abnormalities
大体时间：Baseline (Pre-dose)
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Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
Physical examination abnormalities were judged by the investigator.
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Baseline (Pre-dose)
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Number of Participants With Electrocardiogram (ECG) Abnormalities
大体时间：Baseline up to 24 hours post-dose
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Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec).
Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period.
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Baseline up to 24 hours post-dose
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Number of Participants With Vital Sign Abnormalities
大体时间：Baseline (Pre-dose) up to 24 hours post-dose
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Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.)
increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg.
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Baseline (Pre-dose) up to 24 hours post-dose
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Number of Participants With Laboratory Test Abnormalities
大体时间：Baseline (Pre-dose) up to 24 hours post-dose
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Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower
limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN,
lymphocyte, neutrophil<0.8*LLN,
>1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN,
white blood cell(WBC)<0.6*LLN,>1.5*ULN,
reticulocytes<0.5*LLN,>1.5*ULN;
bilirubin>1.5*ULN,
aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN,
protein, albumin<0.8*LLN,>1.2*ULN;
blood urea nitrogen, creatinine>1.3*ULN,
uric acid>1.2*ULN;
sodium<0.95*LLN,>1.05*ULN,
potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN;
glucose<0.6*LLN,
>1.5*ULN, HbA1c>1.3*ULN,
creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030,
pH<4.5,>8,
WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN;
cholesterol, triglycerides>1.3*ULN,
high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN.
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Baseline (Pre-dose) up to 24 hours post-dose
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Maximum Plasma Concentration (Cmax) of PF-04447943
大体时间：Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
大体时间：Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
大体时间：Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Area under the plasma concentration-time from time zero to time of last measurable concentration.
Observed using the linear/log trapezoidal method.
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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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)
2016年6月29日
初级完成 (实际的)
2016年10月20日
研究完成 (实际的)
2016年10月20日
研究注册日期
首次提交
2016年5月25日
首先提交符合 QC 标准的
2016年5月25日
首次发布 (估计)
2016年5月30日
研究记录更新
最后更新发布 (实际的)
2018年12月28日
上次提交的符合 QC 标准的更新
2018年6月18日
最后验证
2018年6月1日
更多信息
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.