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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Healthy
Interventions Drug: CP-690,550
Drug: Placebo
Drug: Moxifloxacin
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 100 mg Then Placebo Then Moxifloxacin 400 mg CP-690,550 100 mg Then Moxifloxacin 400 mg Then Placebo Placebo Then CP-690,550 100 mg Then Moxifloxacin 400 mg Placebo Then Moxifloxacin 400 mg Then CP-690,550 100 mg Moxifloxacin 400 mg Then CP-690,550 100 mg Then Placebo Moxifloxacin 400 mg Then Placebo Then CP-690,550 100 mg
Hide Arm/Group Description Single oral dose of CP-690,550 100 milligram (mg) (5 x 20 mg tablets) in first intervention period; followed by single oral dose of placebo matched to CP-690,550 tablets in second intervention period; and single oral dose of moxifloxacin 400 mg tablet in third intervention period. A washout period of at least 7 days was maintained between each intervention period. Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in first intervention period; followed by single oral dose of moxifloxacin 400 mg tablet in second intervention period; and single oral dose of placebo matched to CP-690,550 tablets in third intervention period. A washout period of at least 7 days was maintained between each intervention period. Single oral dose of placebo matched to CP-690,550 tablets in first intervention period; followed by single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in second intervention period; and single oral dose of moxifloxacin 400 mg tablet in third intervention period. A washout period of at least 7 days was maintained between each intervention period. Single oral dose of placebo matched to CP-690,550 tablets in first intervention period; followed by single oral dose of moxifloxacin 400 mg tablet in second intervention period; and single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in third intervention period. A washout period of at least 7 days was maintained between each intervention period. Single oral dose of moxifloxacin 400 mg tablet in first intervention period; followed by single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in second intervention period; and single oral dose of placebo matched to CP-690,550 tablets in third intervention period. A washout period of at least 7 days was maintained between each intervention period. Single oral dose of moxifloxacin 400 mg tablet in first intervention period; followed by single oral dose of placebo matched to CP-690,550 tablets in second intervention period; and single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in third intervention period. A washout period of at least 7 days was maintained between each intervention period.
Period Title: First Intervention Period
Started 10 10 10 10 10 10
Completed 10 10 10 10 10 10
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 1 (at Least 7 Days)
Started 10 10 10 10 10 10
Completed 10 10 10 10 10 10
Not Completed 0 0 0 0 0 0
Period Title: Second Intervention Period
Started 10 10 10 10 10 10
Completed 10 10 10 10 10 10
Not Completed 0 0 0 0 0 0
Period Title: Washout Period 2 (at Least 7 Days)
Started 10 10 10 10 10 10
Completed 10 10 10 10 10 10
Not Completed 0 0 0 0 0 0
Period Title: Third Intervention Period
Started 10 10 10 10 10 10
Completed 10 10 10 10 10 10
Not Completed 0 0 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes participants randomized to receive any treatment (CP-690,550 100 mg first, moxifloxacin 400 mg first, or placebo first).
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
32.7  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
28
  46.7%
Male
32
  53.3%
1.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.25 Hour Post-Dose
Hide Description 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).
Time Frame 0.25 hour post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: milliseconds (msec)
416.48  (0.8823) 417.77  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.29
Confidence Interval (2-Sided) 90%
-3.15 to 0.56
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 0.5 Hour Post-Dose
Hide Description 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).
Time Frame 0.5 hour post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
414.70  (0.8823) 416.12  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.42
Confidence Interval (2-Sided) 90%
-3.28 to 0.43
Estimation Comments [Not Specified]
3.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 1 Hour Post-Dose
Hide Description 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).
Time Frame 1 hour post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
414.69  (0.8823) 416.98  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.29
Confidence Interval (2-Sided) 90%
-4.15 to -0.44
Estimation Comments [Not Specified]
4.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 2 Hours Post-Dose
Hide Description 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).
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
413.70  (0.8823) 415.05  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.35
Confidence Interval (2-Sided) 90%
-3.21 to 0.50
Estimation Comments [Not Specified]
5.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 4 Hours Post-Dose
Hide Description 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).
Time Frame 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
416.83  (0.8823) 415.76  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
-0.78 to 2.93
Estimation Comments [Not Specified]
6.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 8 Hours Post-Dose
Hide Description 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).
Time Frame 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
409.25  (0.8823) 408.39  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.86
Confidence Interval (2-Sided) 90%
-1.00 to 2.71
Estimation Comments [Not Specified]
7.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 12 Hours Post-Dose
Hide Description 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).
Time Frame 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
411.39  (0.8823) 410.24  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.15
Confidence Interval (2-Sided) 90%
-0.71 to 3.00
Estimation Comments [Not Specified]
8.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 16 Hours Post-Dose
Hide Description 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).
Time Frame 16 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
415.87  (0.8823) 413.72  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.15
Confidence Interval (2-Sided) 90%
0.29 to 4.00
Estimation Comments [Not Specified]
9.Primary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 24 Hours Post-Dose
Hide Description 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).
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
412.53  (0.8823) 411.18  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.35
Confidence Interval (2-Sided) 90%
-0.50 to 3.21
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo
Hide Description 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).
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description:
Single oral dose of moxifloxacin 400 mg tablet in any intervention period.
Single oral dose of placebo matched to moxifloxacin 400 mg in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
426.34  (0.8823) 415.05  (0.8823)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin 400 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 11.29
Confidence Interval (2-Sided) 90%
9.62 to 12.96
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo
Hide Description 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).
Time Frame 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ECG analysis set included all randomized and treated participants who had at least 1 post-dose ECG measurement in at least 1 period of the crossover.
Arm/Group Title CP-690,550 100 mg Placebo
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Single oral dose of placebo matched to CP-690,550 tablets in any intervention period.
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Error)
Unit of Measure: msec
0.25 Hour Post-Dose 416.40  (1.1139) 416.24  (1.1139)
0.5 Hour Post-Dose 416.69  (1.1139) 414.91  (1.1139)
1 Hour Post-Dose 417.98  (1.1139) 414.99  (1.1139)
2 Hours Post-Dose 414.54  (1.1139) 413.46  (1.1139)
4 Hours Post-Dose 417.26  (1.1139) 415.10  (1.1139)
8 Hours Post-Dose 412.91  (1.1139) 412.86  (1.1139)
12 Hours Post-Dose 416.76  (1.1139) 416.27  (1.1139)
16 Hours Post-Dose 416.44  (1.1139) 414.33  (1.1139)
24 Hours Post-Dose 413.93  (1.1139) 413.14  (1.1139)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 0.25 hour post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 90%
-2.11 to 2.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 0.5 hour post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.78
Confidence Interval (2-Sided) 90%
-0.49 to 4.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 1 hour post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.99
Confidence Interval (2-Sided) 90%
0.71 to 5.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 2 hours post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
-1.19 to 3.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 4 hours post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.16
Confidence Interval (2-Sided) 90%
-0.11 to 4.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 8 hours post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-2.22 to 2.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 12 hours post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.49
Confidence Interval (2-Sided) 90%
-1.79 to 2.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 16 hours post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.10
Confidence Interval (2-Sided) 90%
-0.17 to 4.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection CP-690,550 100 mg, Placebo
Comments 24 hours post-dose
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.79
Confidence Interval (2-Sided) 90%
-1.49 to 3.06
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-690,550
Hide Description 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 - ∞).
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram*hour/milliliter (ng*hr/mL)
2682.6  (778.15)
13.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-690,550
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
2669.7  (771.02)
14.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of CP-690,550
Hide Description [Not Specified]
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
563.5  (199.23)
15.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550
Hide Description [Not Specified]
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in all intervention periods.
Overall Number of Participants Analyzed 60
Median (Full Range)
Unit of Measure: hours
1.000
(0.30 to 4.08)
16.Secondary Outcome
Title Plasma Decay Half-Life (t1/2) of CP-690,550
Hide Description Plasma decay half-life is the time measured for the plasma concentration of drug to decrease by one half.
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: hours
3.284  (0.4871)
17.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of CP-690,550 by Cytochrome P450 2C19 (CYP2C19) Genotype
Hide Description 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.
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here 'number analyzed' signifies those participants who were evaluable in each specific category.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Poor Metabolizer Number Analyzed 6 participants
3127.5  (373.18)
Extensive Metabolizer Number Analyzed 52 participants
2683.5  (787.75)
Ultra Extensive Metabolizer Number Analyzed 2 participants
1677.7  (637.68)
18.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-690,550 by CYP2C19 Genotype
Hide Description 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.
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here 'number analyzed' signifies those participants who were evaluable in each specific category.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Poor Metabolizer Number Analyzed 6 participants
3114.3  (366.68)
Extensive Metabolizer Number Analyzed 52 participants
2670.2  (780.41)
Ultra Extensive Metabolizer Number Analyzed 2 participants
1673.1  (636.30)
19.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of CP-690,550 by CYP2C19 Genotype
Hide Description 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 Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here 'number analyzed' signifies those participants who were evaluable in each specific category.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
Poor Metabolizer Number Analyzed 6 participants
647.4  (281.69)
Extensive Metabolizer Number Analyzed 52 participants
565.0  (185.62)
Ultra Extensive Metabolizer Number Analyzed 2 participants
346.9  (214.25)
20.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-690,550 by CYP2C19 Genotype
Hide Description 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.
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here 'number analyzed' signifies those participants who were evaluable in each specific category.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Median (Full Range)
Unit of Measure: hours
Poor Metabolizer Number Analyzed 6 participants
0.500
(0.30 to 4.03)
Extensive Metabolizer Number Analyzed 52 participants
1.000
(0.30 to 4.08)
Ultra Extensive Metabolizer Number Analyzed 2 participants
2.000
(2.00 to 2.00)
21.Secondary Outcome
Title Plasma Decay Half-Life (t1/2) of CP-690,550 by CYP2C19 Genotype
Hide Description 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.
Time Frame 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here 'number analyzed' signifies those participants who were evaluable in each specific category.
Arm/Group Title CP-690,550 100 mg
Hide Arm/Group Description:
Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: hours
Poor Metabolizer Number Analyzed 6 participants
3.005  (0.3566)
Extensive Metabolizer Number Analyzed 52 participants
3.320  (0.5006)
Ultra Extensive Metabolizer Number Analyzed 2 participants
3.201  (0.1821)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant , or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-690,550 100 mg Placebo Moxifloxacin
Hide Arm/Group Description Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period. Single oral dose of placebo matched to CP-690,550 tablets in any intervention period. Single oral dose of moxifloxacin 400 mg tablet in any intervention period.
All-Cause Mortality
CP-690,550 100 mg Placebo Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CP-690,550 100 mg Placebo Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CP-690,550 100 mg Placebo Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/60 (53.33%)   6/60 (10.00%)   10/60 (16.67%) 
Cardiac disorders       
Palpitations * 1  1/60 (1.67%)  0/60 (0.00%)  0/60 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  3/60 (5.00%)  0/60 (0.00%)  0/60 (0.00%) 
Abdominal distension * 1  1/60 (1.67%)  0/60 (0.00%)  0/60 (0.00%) 
Abdominal pain * 1  2/60 (3.33%)  0/60 (0.00%)  1/60 (1.67%) 
Diarrhoea * 1  2/60 (3.33%)  0/60 (0.00%)  2/60 (3.33%) 
Eructation * 1  1/60 (1.67%)  0/60 (0.00%)  0/60 (0.00%) 
Nausea * 1  17/60 (28.33%)  0/60 (0.00%)  0/60 (0.00%) 
Stomach discomfort * 1  0/60 (0.00%)  0/60 (0.00%)  1/60 (1.67%) 
Toothache * 1  2/60 (3.33%)  0/60 (0.00%)  0/60 (0.00%) 
Vomiting * 1  6/60 (10.00%)  0/60 (0.00%)  0/60 (0.00%) 
Infections and infestations       
Gastroenteritis * 1  0/60 (0.00%)  1/60 (1.67%)  1/60 (1.67%) 
Nasopharyngitis * 1  1/60 (1.67%)  0/60 (0.00%)  0/60 (0.00%) 
Oral herpes * 1  0/60 (0.00%)  1/60 (1.67%)  1/60 (1.67%) 
Injury, poisoning and procedural complications       
Joint sprain * 1  0/60 (0.00%)  1/60 (1.67%)  0/60 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain * 1  1/60 (1.67%)  0/60 (0.00%)  0/60 (0.00%) 
Nervous system disorders       
Dizziness * 1  2/60 (3.33%)  0/60 (0.00%)  2/60 (3.33%) 
Headache * 1  17/60 (28.33%)  1/60 (1.67%)  2/60 (3.33%) 
Syncope vasovagal * 1  1/60 (1.67%)  0/60 (0.00%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/60 (1.67%)  1/60 (1.67%)  0/60 (0.00%) 
Pharyngolaryngeal pain * 1  1/60 (1.67%)  1/60 (1.67%)  2/60 (3.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01743677    
Other Study ID Numbers: A3921028
2007-004492-19 ( EudraCT Number )
First Submitted: October 25, 2012
First Posted: December 6, 2012
Results First Submitted: December 6, 2012
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020