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This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects. This is conducted as part of standard drug development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04447943 low dose | Experimental | 25 mg of PF-04447943 |
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| PF-04447943 high dose | Experimental | 100 mg of PF-04447943 |
|
| Placebo | Placebo Comparator | Matching placebo for PF-04447943 |
|
| Moxifloxacin | Active Comparator | 400 mg of moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04447943 | Drug | Single oral dose of PF-04447943 administered as an extemporaneously prepared solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 0.5 hour post-dose |
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 1 hour post-dose |
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 2 hours post-dose |
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 3 hours post-dose |
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis. | 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose |
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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 New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin, Placebo, PF-04447943 100 mg, PF-04447943 25 mg | Participants received a single oral dose of Moxifloxacin 400 milligram (mg) tablet on Day 1 in the first intervention period; followed by a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication. |
| FG001 | PF-04447943 25 mg, Moxifloxacin, Placebo, PF-04447943 100 mg | Participants received a single dose of oral solution of PF-04447943 25 mg on Day 1 in the first intervention period; followed by a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the second intervention period; then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication. |
| FG002 | Placebo, PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin | Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 100 mg on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the third intervention period; and then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication. |
| FG003 | PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin, Placebo | Participants received a single dose of oral solution of PF-04447943 100 mg on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 25 mg on Day 1 in the second intervention period; then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the third intervention period; and then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 (1 Day) |
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| Washout Period 1 (7 Days) |
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| Intervention Period 2 (1 Day) |
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| Washout Period 2 (7 Days) |
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| Intervention Period 3 (1 Day) |
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| Washout Period 3 (7 Days) |
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| Intervention Period 4 (1 Day) |
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Analysis set included all participants who were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who were randomized to receive Moxifloxacin first, placebo first, PF-04447943 100 mg first and PF-04447943 25 mg first in intervention period 1. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose |
|
Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
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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 | PF-04447943 25 mg | Participants received a single dose of oral solution of PF-04447943 25 mg on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | 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 |
|---|---|
| C572323 | 6-(4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl)-1-(tetrahydro-2H-pyran-4-yl)-1,5-dihydro-4H-pyrazolo(3,4-d)pyrimidin-4-one |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo | Drug | Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution |
|
| Moxifloxacin | Drug | Single oral dose of moxifloxacin administered as tablet |
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. |
| 4 hours post-dose |
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 8 hours post-dose |
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 12 hours post-dose |
| Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 24 hours post-dose |
| Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo | Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose |
| Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo | Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
| Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo | Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. | Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days) |
| Number of Participants With Physical Examination Abnormalities | Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Physical examination abnormalities were judged by the investigator. | Baseline (Pre-dose) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec). Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period. | Baseline up to 24 hours post-dose |
| Number of Participants With Vital Sign Abnormalities | Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.) increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg. | Baseline (Pre-dose) up to 24 hours post-dose |
| Number of Participants With Laboratory Test Abnormalities | Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN, lymphocyte, neutrophil<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN, white blood cell(WBC)<0.6*LLN,>1.5*ULN, reticulocytes<0.5*LLN,>1.5*ULN; bilirubin>1.5*ULN, aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN, protein, albumin<0.8*LLN,>1.2*ULN; blood urea nitrogen, creatinine>1.3*ULN, uric acid>1.2*ULN; sodium<0.95*LLN,>1.05*ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN; glucose<0.6*LLN, >1.5*ULN, HbA1c>1.3*ULN, creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030, pH<4.5,>8, WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN; cholesterol, triglycerides>1.3*ULN, high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN. | Baseline (Pre-dose) up to 24 hours post-dose |
| Maximum Plasma Concentration (Cmax) of PF-04447943 | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
| Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943 | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943 | Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method. | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 |
| Placebo |
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication. |
|
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | Electrocardiogram (ECG) analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Millisecond (Msec) | 0.5 hour post-dose |
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 1 hour post-dose |
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 2 hours post-dose |
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 3 hours post-dose |
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 4 hours post-dose |
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 8 hours post-dose |
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 12 hours post-dose |
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| Primary | Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose | Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. | Posted | Least Squares Mean | Standard Error | Msec | 24 hours post-dose |
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| Secondary | Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo | Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. This outcome measure was planned not to be analyzed for reporting group: Moxifloxacin 400 mg. | Posted | Least Squares Mean | Standard Error | Beats per minute (bpm) | 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose |
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| Secondary | Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo | Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. This outcome measure was planned not to be analyzed for reporting group: Moxifloxacin 400 mg. | Posted | Least Squares Mean | Standard Error | Msec | 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
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| Secondary | Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo | Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis. | ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. The outcome measure was planned not to be analyzed for reporting group: Moxifloxacin 400 mg. | Posted | Least Squares Mean | Standard Error | Msec | 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days) |
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| Secondary | Number of Participants With Physical Examination Abnormalities | Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Physical examination abnormalities were judged by the investigator. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline (Pre-dose) |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec). Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 24 hours post-dose |
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| Secondary | Number of Participants With Vital Sign Abnormalities | Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.) increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg. | Safety analysis set included all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline (Pre-dose) up to 24 hours post-dose |
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| Secondary | Number of Participants With Laboratory Test Abnormalities | Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN, lymphocyte, neutrophil<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN, white blood cell(WBC)<0.6*LLN,>1.5*ULN, reticulocytes<0.5*LLN,>1.5*ULN; bilirubin>1.5*ULN, aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN, protein, albumin<0.8*LLN,>1.2*ULN; blood urea nitrogen, creatinine>1.3*ULN, uric acid>1.2*ULN; sodium<0.95*LLN,>1.05*ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN; glucose<0.6*LLN, >1.5*ULN, HbA1c>1.3*ULN, creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030, pH<4.5,>8, WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN; cholesterol, triglycerides>1.3*ULN, high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline (Pre-dose) up to 24 hours post-dose |
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| Secondary | Maximum Plasma Concentration (Cmax) of PF-04447943 | Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
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| Secondary | Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943 | PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest. | Posted | Median | Full Range | Hours | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943 | Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method. | PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 7 |
| 43 |
| EG001 | PF-04447943 100 mg | Participants received a single dose of oral solution of PF-04447943 100 mg on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication. | 0 | 42 | 0 | 42 | 3 | 42 |
| EG002 | Moxifloxacin 400 mg | Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication. | 0 | 41 | 0 | 41 | 3 | 41 |
| EG003 | Placebo | Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication. | 0 | 42 | 0 | 42 | 2 | 42 |
| Headache | Nervous system disorders | MedDRA 19.0 | 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 |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.0004 |
| LS Mean Difference |
| 4.54 |
| 2-Sided |
| 90 |
| 2.44 |
| 6.64 |
| Superiority or Other |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| <0.0001 |
| LS mean difference |
| 5.04 |
| 2-Sided |
| 90 |
| 2.95 |
| 7.14 |
| Superiority or Other |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.0009 |
| LS mean difference |
| 4.26 |
| 2-Sided |
| 90 |
| 2.16 |
| 6.36 |
| Superiority or Other |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.0768 |
| LS mean difference |
| 2.26 |
| 2-Sided |
| 90 |
| 0.16 |
| 4.36 |
| Superiority or Other |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.3424 |
| LS mean difference |
| 1.21 |
| 2-Sided |
| 90 |
| -0.89 |
| 3.31 |
| Superiority or Other |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.9334 |
| LS mean difference |
| -0.11 |
| 2-Sided |
| 90 |
| -2.21 |
| 1.99 |
| Superiority or Other |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.0412 |
| LS mean difference |
| -2.61 |
| 2-Sided |
| 90 |
| -4.71 |
| -0.51 |
| Superiority or Other |
PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.0294 |
| LS mean difference |
| -2.78 |
| 2-Sided |
| 90 |
| -4.88 |
| -0.68 |
| Superiority or Other |
|
| 2 Hours |
|
| 3 Hours |
|
| 4 Hours |
|
| 8 Hours |
|
| 12 Hours |
|
| 24 Hours |
|
PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.0092 |
| LS mean difference |
| 2.38 |
| 2-Sided |
| 90 |
| 0.88 |
| 3.87 |
| Superiority or Other |
| PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3174 | LS mean difference | 0.91 | 2-Sided | 90 | -0.59 | 2.41 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.7344 | LS mean difference | -0.31 | 2-Sided | 90 | -1.81 | 1.19 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.5881 | LS mean difference | 0.49 | 2-Sided | 90 | -1.00 | 1.99 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3680 | LS mean difference | -0.82 | 2-Sided | 90 | -2.32 | 0.68 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.4200 | LS mean difference | -0.73 | 2-Sided | 90 | -2.23 | 0.76 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0009 | LS mean difference | -3.03 | 2-Sided | 90 | -4.53 | -1.53 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | < 0.0001 | LS mean difference | 4.46 | 2-Sided | 90 | 2.96 | 5.97 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | < 0.0001 | LS mean difference | 5.83 | 2-Sided | 90 | 4.32 | 7.33 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | < 0.0001 | LS mean difference | 4.09 | 2-Sided | 90 | 2.58 | 5.59 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0059 | LS mean difference | 2.53 | 2-Sided | 90 | 1.02 | 4.03 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0063 | LS mean difference | 2.50 | 2-Sided | 90 | 1.00 | 4.01 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.1138 | LS mean difference | 1.45 | 2-Sided | 90 | -0.06 | 2.95 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.6976 | LS mean difference | -0.36 | 2-Sided | 90 | -1.86 | 1.15 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0208 | LS mean difference | -2.12 | 2-Sided | 90 | -3.62 | -0.61 | Superiority or Other |
|
| 2 Hours |
|
| 3 Hours |
|
| 4 Hours |
|
| 8 Hours |
|
| 12 Hours |
|
| 24 Hours |
|
PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.4126 |
| LS mean difference |
| -0.94 |
| 2-Sided |
| 90 |
| -2.83 |
| 0.95 |
| Superiority or Other |
| PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3085 | LS mean difference | -1.17 | 2-Sided | 90 | -3.06 | 0.72 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3889 | LS mean difference | -0.99 | 2-Sided | 90 | -2.88 | 0.90 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.6192 | LS mean difference | -0.57 | 2-Sided | 90 | -2.46 | 1.32 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0332 | LS mean difference | -2.45 | 2-Sided | 90 | -4.34 | -0.56 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.7224 | LS mean difference | -0.41 | 2-Sided | 90 | -2.30 | 1.48 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.6507 | LS mean difference | 0.52 | 2-Sided | 90 | -1.37 | 2.41 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.1366 | LS mean difference | -1.72 | 2-Sided | 90 | -3.62 | 0.18 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0153 | LS mean difference | -2.81 | 2-Sided | 90 | -4.71 | -0.91 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.1040 | LS mean difference | -1.88 | 2-Sided | 90 | -3.78 | 0.02 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.1924 | LS mean difference | -1.51 | 2-Sided | 90 | -3.41 | 0.40 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0928 | LS mean difference | -1.94 | 2-Sided | 90 | -3.84 | -0.04 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0745 | LS mean difference | -2.06 | 2-Sided | 90 | -3.96 | -0.16 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3836 | LS mean difference | -1.01 | 2-Sided | 90 | -2.91 | 0.90 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0734 | LS mean difference | -2.07 | 2-Sided | 90 | -3.97 | -0.17 | Superiority or Other |
|
| 2 Hours |
|
| 3 Hours |
|
| 4 Hours |
|
| 8 Hours |
|
| 12 Hours |
|
| 24 Hours |
|
PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. |
| Repeated Measures Model |
| 0.8465 |
| LS mean difference |
| 0.14 |
| 2-Sided |
| 90 |
| -1.03 |
| 1.30 |
| Superiority or Other |
| PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.1502 | LS mean difference | 1.02 | 2-Sided | 90 | -0.15 | 2.18 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.9700 | LS mean difference | -0.03 | 2-Sided | 90 | -1.19 | 1.14 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0947 | LS mean difference | -1.18 | 2-Sided | 90 | -2.34 | -0.02 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.7759 | LS mean difference | 0.20 | 2-Sided | 90 | -0.96 | 1.36 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.9649 | LS mean difference | 0.03 | 2-Sided | 90 | -1.13 | 1.19 | Superiority or Other |
| PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.9034 | LS mean difference | 0.09 | 2-Sided | 90 | -1.08 | 1.25 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3391 | LS mean difference | -0.68 | 2-Sided | 90 | -1.85 | 0.49 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0948 | LS mean difference | -1.19 | 2-Sided | 90 | -2.35 | -0.02 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.2959 | LS mean difference | -0.74 | 2-Sided | 90 | -1.91 | 0.43 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.9161 | LS mean difference | -0.07 | 2-Sided | 90 | -1.24 | 1.09 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.0036 | LS mean difference | -2.07 | 2-Sided | 90 | -3.24 | -0.91 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3063 | LS mean difference | -0.73 | 2-Sided | 90 | -1.89 | 0.44 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.4918 | LS mean difference | -0.49 | 2-Sided | 90 | -1.65 | 0.68 | Superiority or Other |
| PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect. | Repeated Measures Model | 0.3862 | LS mean difference | -0.61 | 2-Sided | 90 | -1.78 | 0.55 | Superiority or Other |
| SAEs |
|
| QTcB Interval 480 to <500 msec |
|
| QTcB Interval >=500 msec |
|
| QTcB IFB (>= 30 to <60) msec |
|
| QTcB IFB (>=60) msec |
|
| QTcF Interval 450 to <480 msec |
|
| QTcF Interval 480 to <500 msec |
|
| QTcF Interval >=500 msec |
|
| QTcF IFB (>=30 to <60) msec |
|
| QTcF IFB (>=60) msec |
|
| Standing SBP: <90 mmHg |
|
| Supine DBP: <50 mmHg |
|
| Standing DBP: <50 mmHg |
|
| Supine Pulse Rate: <40 bpm |
|
| Supine Pulse Rate: >120 bpm |
|
| Standing Pulse Rate: <40 bpm |
|
| Standing Pulse Rate: >120 bpm |
|
| Max. IFB in Supine SBP: >=30mmHg |
|
| Max. IFB in StandingSBP:>=30 mmHg |
|
| Max. IFB in Supine DBP: >=20 mmHg |
|
| Max. IFB in StandingDBP:>=20 mmHg |
|
| Max. DFB in Supine SBP:>=30 mmHg |
|
| Max. DFB in StandingSBP:>=30 mmHg |
|
| Max. DFB in Supine DBP:>=20 mmHg |
|
| Max. DFB in StandingDBP:>=20 mmHg |
|