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CP-690,550 Thorough QTc Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01743677
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 25, 2012
First Posted Date  ICMJE December 6, 2012
Results First Submitted Date  ICMJE December 6, 2012
Results First Posted Date  ICMJE September 16, 2020
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE October 26, 2007
Actual Primary Completion Date February 7, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.25 Hour Post-Dose [ Time Frame: 0.25 hour post-dose ]
    Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as Least Squares (LS) mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.5 Hour Post-Dose [ Time Frame: 0.5 hour post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 1 Hour Post-Dose [ Time Frame: 1 hour post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 2 Hours Post-Dose [ Time Frame: 2 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 4 Hours Post-Dose [ Time Frame: 4 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 8 Hours Post-Dose [ Time Frame: 8 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 12 Hours Post-Dose [ Time Frame: 12 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 16 Hours Post-Dose [ Time Frame: 16 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 24 Hours Post-Dose [ Time Frame: 24 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 0.25 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 0.5 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 1 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 2 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 4 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 8 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 12 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 16 hr postdose ]
  • Time-matched mean differences in QTcF intervals between CP-690,550 and placebo (baseline-adjusted) at each postdose time [ Time Frame: 24 hr postdose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo [ Time Frame: 2 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Data is reported as LS mean difference (moxifloxacin minus Placebo, baseline-adjusted).
  • Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo [ Time Frame: 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours post-dose ]
    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The QT interval was adjusted for RR interval using the QT and RR from each ECG by Bazett's formula (QTcB = QT divided by square root of RR). Data is reported as LS mean difference (CP-690,550 minus Placebo, baseline-adjusted).
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-690,550 [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-690,550 [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
  • Maximum Observed Plasma Concentration (Cmax) of CP-690,550 [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550 [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
  • Plasma Decay Half-Life (t1/2) of CP-690,550 [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration of drug to decrease by one half.
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of CP-690,550 by Cytochrome P450 2C19 (CYP2C19) Genotype [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Variation in CYP2C19 gene affected the pharmacokinetics of CP-690,550. AUC (0 - ∞) categorized by genotype into poor metabolizer, extensive metabolizer and ultra extensive metabolizer of CYP2C19.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-690,550 by CYP2C19 Genotype [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Variation in CYP2C19 gene affected the pharmacokinetics of CP-690,550. AUClast categorized by genotype as poor metabolizer, extensive metabolizer and ultra extensive metabolizer of CYP2C19.
  • Maximum Observed Plasma Concentration (Cmax) of CP-690,550 by CYP2C19 Genotype [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    Variation in CYP2C19 gene affected the pharmacokinetics of CP-690,550. Cmax categorized by genotype as poor metabolizer, extensive metabolizer and ultra extensive metabolizer of CYP2C19.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-690,550 by CYP2C19 Genotype [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    Variation in CYP2C19 gene affected the pharmacokinetics of CP-690,550. Tmax categorized by genotype as poor metabolizer, extensive metabolizer and ultra extensive metabolizer of CYP2C19.
  • Plasma Decay Half-Life (t1/2) of CP-690,550 by CYP2C19 Genotype [ Time Frame: 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Variation in CYP2C19 gene affected the pharmacokinetics of CP-690,550. t1/2 categorized by genotype as poor metabolizer, extensive metabolizer and ultra extensive metabolizer of CYP2C19.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo [ Time Frame: -1, -0.5, and 0 hrs predose and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hr postdose ]
  • Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo [ Time Frame: -1, -0.5, and 0 hrs predose and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hr postdose ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-infinity)] [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUClast) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-infinity)] by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Maximum Observed Plasma Concentration (Cmax) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
  • Plasma Decay Half-Life (t1/2) by CYP2C19 Genotype [ Time Frame: predose, 0.25,0.5,1,2,4,8,12,16 and 24 hr postdose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CP-690,550 Thorough QTc Study
Official Title  ICMJE A PHASE 1, RANDOMIZED, PLACEBO- AND POSITIVE-CONTROLLED CROSS-OVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE CP-690,550 ON QTC INTERVAL IN HEALTHY VOLUNTEERS
Brief Summary ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development. The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation.
Detailed Description The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CP-690,550
    Single dose 100 mg (5 x 20 mg tablets)
  • Drug: Placebo
    Single dose placebo tablets (5 tablets)
  • Drug: Moxifloxacin
    Single dose Avelox 400 mg tablet
Study Arms  ICMJE
  • Experimental: CP-690,550 100 mg
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Moxifloxacin hydrochloride
    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: December 4, 2012)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 9, 2008
Actual Primary Completion Date February 7, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Use of tobacco- or nicotine-containing products in excess of equivalent of 5 cigarettes per day.
  • 12-lead ECG demonstrating QTc >450 msec or other clinically significant abnormalities at Screening.
  • History of risk factors for QT prolongation or torsades de pointes.
  • Pregnant or nursing women; women of childbearing potential unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to first dose until completion of follow-up.
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.
  • Any clinically significant infections within past 3 months or evidence of infection in past 7 days.
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 Belgium,   Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01743677
Other Study ID Numbers  ICMJE A3921028
2007-004492-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 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.
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 August 2020

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