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A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02785770
Recruitment Status : Completed
First Posted : May 30, 2016
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE May 30, 2016
Results First Submitted Date  ICMJE September 5, 2017
Results First Posted Date  ICMJE December 28, 2018
Last Update Posted Date December 28, 2018
Actual Study Start Date  ICMJE June 29, 2016
Actual Primary Completion Date October 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • 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 [ Time Frame: 0.5 hour post-dose ]
    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.
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose [ Time Frame: 1 hour post-dose ]
    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.
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ]
    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.
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose [ Time Frame: 3 hours post-dose ]
    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.
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose [ Time Frame: 4 hours post-dose ]
    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.
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose [ Time Frame: 8 hours post-dose ]
    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.
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose [ Time Frame: 12 hours post-dose ]
    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.
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose [ Time Frame: 24 hours post-dose ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Time matched mean differences in QTc interval using Fridericia's correction method (QTcF), or other correction method if warranted, between PF 04447943 and placebo at each post dose time point [ Time Frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo [ Time Frame: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose ]
    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.
  • Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo [ Time Frame: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose ]
    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.
  • Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo [ Time Frame: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose ]
    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.
  • Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo [ Time Frame: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose ]
    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.
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days) ]
    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.
  • Number of Participants With Physical Examination Abnormalities [ Time Frame: Baseline (Pre-dose) ]
    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.
  • Number of Participants With Electrocardiogram (ECG) Abnormalities [ Time Frame: Baseline up to 24 hours post-dose ]
    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.
  • Number of Participants With Vital Sign Abnormalities [ Time Frame: Baseline (Pre-dose) up to 24 hours post-dose ]
    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.
  • Number of Participants With Laboratory Test Abnormalities [ Time Frame: Baseline (Pre-dose) up to 24 hours post-dose ]
    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.
  • Maximum Plasma Concentration (Cmax) of PF-04447943 [ Time Frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose ]
  • Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943 [ Time Frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose ]
  • Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943 [ Time Frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose ]
    Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • Time matched mean differences in QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours [ Time Frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
  • Time matched mean differences in heart rate between PF-04447943 and placebo [ Time Frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: 0-24 hours post dose ]
  • Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance [ Time Frame: 0-24 hours post dose ]
  • Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance [ Time Frame: 0-24 hours post dose ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-04447943 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04447943 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04447943 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
  • Time matched mean differences in PR intervals between PF-04447943 and placebo [ Time Frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
  • Time matched mean differences in QRS intervals between PF-04447943 and placebo [ Time Frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04447943
    Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
  • Drug: Placebo
    Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
  • Drug: Moxifloxacin
    Single oral dose of moxifloxacin administered as tablet
Study Arms  ICMJE
  • Experimental: PF-04447943 low dose
    25 mg of PF-04447943
    Intervention: Drug: PF-04447943
  • Experimental: PF-04447943 high dose
    100 mg of PF-04447943
    Intervention: Drug: PF-04447943
  • Placebo Comparator: Placebo
    Matching placebo for PF-04447943
    Intervention: Drug: Placebo
  • Active Comparator: Moxifloxacin
    400 mg of moxifloxacin
    Intervention: Drug: Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 20, 2016
Actual Primary Completion Date October 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02785770
Other Study ID Numbers  ICMJE B0401018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP