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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004492-19 | EudraCT Number |
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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.
The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-690,550 100 mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Moxifloxacin hydrochloride | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 | Drug | Single dose 100 mg (5 x 20 mg tablets) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 0.25 hour post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 0.5 hour post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 1 hour post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | 1070 | Belgium | |||
| Pfizer Clinical Research Unit |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CP-690,550 100 mg Then Placebo Then Moxifloxacin 400 mg | 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. |
| FG001 | CP-690,550 100 mg Then Moxifloxacin 400 mg Then Placebo | 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. |
| FG002 | Placebo Then CP-690,550 100 mg Then Moxifloxacin 400 mg | 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. |
| FG003 | Placebo Then Moxifloxacin 400 mg Then CP-690,550 100 mg | 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. |
| FG004 | Moxifloxacin 400 mg Then CP-690,550 100 mg Then Placebo | 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. |
| FG005 | Moxifloxacin 400 mg Then Placebo Then CP-690,550 100 mg | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| Washout Period 1 (at Least 7 Days) |
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| Second Intervention Period |
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| Washout Period 2 (at Least 7 Days) |
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| Third Intervention Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes participants randomized to receive any treatment (CP-690,550 100 mg first, moxifloxacin 400 mg first, or placebo first). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | milliseconds (msec) | 0.25 hour post-dose |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP-690,550 100 mg | Single oral dose of CP-690,550 100 mg (5 x 20 mg tablets) in any intervention period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
Single dose placebo tablets (5 tablets) |
|
| Moxifloxacin | Drug | Single dose Avelox 400 mg tablet |
|
| 2 hours post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 4 hours post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 8 hours post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 12 hours post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 16 hours post-dose |
| Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 24 hours post-dose |
| 2 hours post-dose |
| Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo | 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). | 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-690,550 | 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 - ∞). | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-690,550 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of CP-690,550 | 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 | 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 | Plasma decay half-life is the time measured for the plasma concentration of drug to decrease by one half. | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of CP-690,550 by Cytochrome P450 2C19 (CYP2C19) Genotype | 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. | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-690,550 by CYP2C19 Genotype | 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. | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) of CP-690,550 by CYP2C19 Genotype | 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. | 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) of CP-690,550 by CYP2C19 Genotype | 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. | 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 by CYP2C19 Genotype | 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. | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
| Singapore |
| 188770 |
| Singapore |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Placebo | Single oral dose of placebo matched to CP-690,550 tablets in any intervention period. |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 0.5 hour post-dose |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 1 hour post-dose |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 2 hours post-dose |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 4 hours post-dose |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 8 hours post-dose |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 12 hours post-dose |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 16 hours post-dose |
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| Primary | Mean Time-Matched Difference in QTcF Intervals Between CP-690,550 Compared to Placebo at 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 24 hours post-dose |
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| Secondary | Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin Compared to Placebo | 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 2 hours post-dose |
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| Secondary | Mean Time-Matched Difference in QTcB Intervals Between CP-690,550 Compared to Placebo | 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). | 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. | Posted | Least Squares Mean | Standard Error | msec | 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours post-dose |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-690,550 | 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 - ∞). | 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. | Posted | Geometric Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-690,550 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 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. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of CP-690,550 | 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. | Posted | Geometric Mean | Standard Deviation | nanogram/milliliter (ng/mL) | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550 | 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. | Posted | Median | Full Range | hours | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Plasma Decay Half-Life (t1/2) of CP-690,550 | Plasma decay half-life is the time measured for the plasma concentration of drug to decrease by one half. | 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. | Posted | Mean | Standard Deviation | hours | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of CP-690,550 by Cytochrome P450 2C19 (CYP2C19) Genotype | 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. | 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. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-690,550 by CYP2C19 Genotype | 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. | 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. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of CP-690,550 by CYP2C19 Genotype | 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. | 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. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-690,550 by CYP2C19 Genotype | 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. | 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. | Posted | Median | Full Range | hours | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| Secondary | Plasma Decay Half-Life (t1/2) of CP-690,550 by CYP2C19 Genotype | 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. | 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. | Posted | Mean | Standard Deviation | hours | 0 (pre-dose), and 0.25, 0.5, 1, 2, 4, 8, 12, 16 and 24 hours post-dose |
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| 0 |
| 60 |
| 32 |
| 60 |
| EG001 | Placebo | Single oral dose of placebo matched to CP-690,550 tablets in any intervention period. | 0 | 60 | 6 | 60 |
| EG002 | Moxifloxacin | Single oral dose of moxifloxacin 400 mg tablet in any intervention period. | 0 | 60 | 10 | 60 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Syncope vasovagal | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
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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.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 1 Hour Post-Dose |
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| 2 Hours Post-Dose |
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| 4 Hours Post-Dose |
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| 8 Hours Post-Dose |
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| 12 Hours Post-Dose |
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| 16 Hours Post-Dose |
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| 24 Hours Post-Dose |
|
| Least Squares Mean Difference |
| 1.78 |
| 2-Sided |
| 90 |
| -0.49 |
| 4.06 |
| Superiority |
| 1 hour post-dose | Least Squares Mean Difference | 2.99 | 2-Sided | 90 | 0.71 | 5.26 | Superiority |
| 2 hours post-dose | Least Squares Mean Difference | 1.08 | 2-Sided | 90 | -1.19 | 3.36 | Superiority |
| 4 hours post-dose | Least Squares Mean Difference | 2.16 | 2-Sided | 90 | -0.11 | 4.44 | Superiority |
| 8 hours post-dose | Least Squares Mean Difference | 0.05 | 2-Sided | 90 | -2.22 | 2.33 | Superiority |
| 12 hours post-dose | Least Squares Mean Difference | 0.49 | 2-Sided | 90 | -1.79 | 2.76 | Superiority |
| 16 hours post-dose | Least Squares Mean Difference | 2.10 | 2-Sided | 90 | -0.17 | 4.38 | Superiority |
| 24 hours post-dose | Least Squares Mean Difference | 0.79 | 2-Sided | 90 | -1.49 | 3.06 | Superiority |
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| Ultra Extensive Metabolizer |
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| Ultra Extensive Metabolizer |
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| Ultra Extensive Metabolizer |
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| Ultra Extensive Metabolizer |
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| Ultra Extensive Metabolizer |
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