A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
2018년 6월 18일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
44
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06511
- Pfizer New Haven Clinical Research Unit
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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위약 비교기: 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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활성 비교기: Moxifloxacin
400 mg of moxifloxacin
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Single oral dose of moxifloxacin administered as tablet
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 6월 29일
기본 완료 (실제)
2016년 10월 20일
연구 완료 (실제)
2016년 10월 20일
연구 등록 날짜
최초 제출
2016년 5월 25일
QC 기준을 충족하는 최초 제출
2016년 5월 25일
처음 게시됨 (추정)
2016년 5월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 6월 18일
마지막으로 확인됨
2018년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B0401018
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
PF-04447943에 대한 임상 시험
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Pfizer완전한