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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02785770

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects. This is conducted as part of standard drug development.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-04447943 Drug: Placebo Drug: Moxifloxacin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Single-dose, Randomized, 4-treatment, 4-period Crossover, Placebo- And Positive-controlled, Double-blind (Open-label For Positive Control), Sponsor-open Study To Determine The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

Actual Study Start Date :

Jun 29, 2016

Actual Primary Completion Date :

Oct 20, 2016

Actual Study Completion Date :

Oct 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-04447943 low dose 25 mg of PF-04447943	Drug: PF-04447943 Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
Experimental: PF-04447943 high dose 100 mg of PF-04447943	Drug: PF-04447943 Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
Placebo Comparator: Placebo Matching placebo for PF-04447943	Drug: Placebo Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
Active Comparator: Moxifloxacin 400 mg of moxifloxacin	Drug: Moxifloxacin Single oral dose of moxifloxacin administered as tablet

Outcome Measures

Primary Outcome Measures

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 [0.5 hour post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose [1 hour post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose [2 hours post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose [3 hours post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose [4 hours post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose [8 hours post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose [12 hours post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose [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.

Secondary Outcome Measures

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo [0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose]
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo [0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose]
Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo [0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose]
Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo [0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose]
Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.
Number of Participants With Physical Examination Abnormalities [Baseline (Pre-dose)]
Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Physical examination abnormalities were judged by the investigator.
Number of Participants With Electrocardiogram (ECG) Abnormalities [Baseline up to 24 hours post-dose]
Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec). Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period.
Number of Participants With Vital Sign Abnormalities [Baseline (Pre-dose) up to 24 hours post-dose]
Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.) increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg.
Number of Participants With Laboratory Test Abnormalities [Baseline (Pre-dose) up to 24 hours post-dose]
Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN, lymphocyte, neutrophil<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN, white blood cell(WBC)<0.6*LLN,>1.5*ULN, reticulocytes<0.5*LLN,>1.5*ULN; bilirubin>1.5*ULN, aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN, protein, albumin<0.8*LLN,>1.2*ULN; blood urea nitrogen, creatinine>1.3*ULN, uric acid>1.2*ULN; sodium<0.95*LLN,>1.05*ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN; glucose<0.6*LLN, >1.5*ULN, HbA1c>1.3*ULN, creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030, pH<4.5,>8, WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN; cholesterol, triglycerides>1.3*ULN, high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN.
Maximum Plasma Concentration (Cmax) of PF-04447943 [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 [Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose]
Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy female subjects of non childbearing potential and/or healthy male subjects, between the ages of 18 and 55 years.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic brain injury.
History of seizures or history or physical examination findings (eg localizing signs on neurologic examination) suggestive of structural central nervous system (CNS) abnormalities which may place patient at increased risk of seizures.
History of orthostatic blood pressure changes or clinically significant orthostatic symptoms.
Self reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02785770

Other Study ID Numbers:

B0401018

First Posted:

May 30, 2016

Last Update Posted:

Dec 28, 2018

Last Verified:

Jun 1, 2018

Additional relevant MeSH terms:

Moxifloxacin

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Moxifloxacin, Placebo, PF-04447943 100 mg, PF-04447943 25 mg	PF-04447943 25 mg, Moxifloxacin, Placebo, PF-04447943 100 mg	Placebo, PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin	PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin, Placebo
Arm/Group Description	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.	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.	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.	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.
Period Title: Intervention Period 1 (1 Day)
STARTED	11	11	11	11
COMPLETED	11	11	11	11
NOT COMPLETED	0	0	0	0
Period Title: Intervention Period 1 (1 Day)
STARTED	11	11	11	11
COMPLETED	11	11	11	11
NOT COMPLETED	0	0	0	0
Period Title: Intervention Period 1 (1 Day)
STARTED	11	11	11	11
COMPLETED	11	10	10	11
NOT COMPLETED	0	1	1	0
Period Title: Intervention Period 1 (1 Day)
STARTED	11	10	10	11
COMPLETED	11	10	10	11
NOT COMPLETED	0	0	0	0
Period Title: Intervention Period 1 (1 Day)
STARTED	11	10	10	11
COMPLETED	11	10	10	10
NOT COMPLETED	0	0	0	1
Period Title: Intervention Period 1 (1 Day)
STARTED	11	10	10	10
COMPLETED	11	10	10	10
NOT COMPLETED	0	0	0	0
Period Title: Intervention Period 1 (1 Day)
STARTED	11	10	10	10
COMPLETED	11	10	10	10
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	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.
Overall Participants	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.3 (8.8)
Sex: Female, Male (Count of Participants)
Female	1 2.3%
Male	43 97.7%

Outcome Measures

1. Secondary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.
Time Frame	0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	Moxifloxacin 400 mg	Placebo
Arm/Group Description	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.	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.
Measure Participants	41	42
0.5 Hour	405.34 (0.9765)	404.38 (0.9653)
1 Hour	411.98 (0.9765)	404.09 (0.9653)
2 Hours	413.85 (0.9765)	402.52 (0.9653)
3 Hours	413.03 (0.9765)	404.43 (0.9653)
4 Hours	413.69 (0.9765)	404.73 (0.9653)
8 Hours	406.72 (0.9765)	398.66 (0.9653)
12 Hours	407.52 (0.9765)	401.99 (0.9653)
24 Hours	406.81 (0.9765)	403.06 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4540
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 90% -1.15 to 3.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	7.88
	Confidence Interval	(2-Sided) 90% 5.77 to 9.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	11.33
	Confidence Interval	(2-Sided) 90% 9.22 to 13.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	8.59
	Confidence Interval	(2-Sided) 90% 6.48 to 10.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	8.96
	Confidence Interval	(2-Sided) 90% 6.85 to 11.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	8.07
	Confidence Interval	(2-Sided) 90% 5.96 to 10.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	5.53
	Confidence Interval	(2-Sided) 90% 3.42 to 7.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	Moxifloxacin 400 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0036
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	3.74
	Confidence Interval	(2-Sided) 90% 1.64 to 5.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	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
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	0.5 hour post-dose

Outcome Measure Data

Analysis Population Description
Electrocardiogram (ECG) analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Millisecond (Msec)]	404.09 (0.9544)	408.92 (0.9659)	404.38 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8195
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	Least Square (LS) Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 90% -2.38 to 1.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	4.54
	Confidence Interval	(2-Sided) 90% 2.44 to 6.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	1 hour post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Msec]	404.23 (0.9544)	409.14 (0.965)	404.09 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9146
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90% -1.95 to 2.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	5.04
	Confidence Interval	(2-Sided) 90% 2.95 to 7.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	2 hours post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Msec]	403.76 (0.9544)	406.78 (0.9659)	402.52 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3272
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 90% -0.84 to 3.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0009
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	4.26
	Confidence Interval	(2-Sided) 90% 2.16 to 6.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	3 hours post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Msec]	403.95 (0.9544)	406.69 (0.9659)	404.43 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7024
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 90% -2.57 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0768
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.26
	Confidence Interval	(2-Sided) 90% 0.16 to 4.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	4 hours post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Msec]	402.76 (0.9544)	405.94 (0.9659)	404.73 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1201
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.97
	Confidence Interval	(2-Sided) 90% -4.06 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3424
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 90% -0.89 to 3.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	8 hours post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Msec]	397.31 (0.9544)	398.55 (0.9659)	398.66 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2870
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.35
	Confidence Interval	(2-Sided) 90% -3.44 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9334
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 90% -2.21 to 1.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Primary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	12 hours post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Msec]	399.83 (0.9544)	399.38 (0.9659)	401.99 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0893
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.16
	Confidence Interval	(2-Sided) 90% -4.24 to -0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0412
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.61
	Confidence Interval	(2-Sided) 90% -4.71 to -0.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Primary Outcome

Title	Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
Description	Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	24 hours post-dose

Outcome Measure Data

Analysis Population Description
ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
Least Squares Mean (Standard Error) [Msec]	401.72 (0.9544)	400.28 (0.9659)	403.06 (0.9653)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2892
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.34
	Confidence Interval	(2-Sided) 90% -3.43 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0294
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.78
	Confidence Interval	(2-Sided) 90% -4.88 to -0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
Description	Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
0.5 Hour	60.72 (0.6831)	63.91 (0.6911)	59.44 (0.6910)
1 Hour	60.98 (0.6831)	64.43 (0.6911)	58.60 (0.6910)
2 Hours	58.55 (0.6831)	61.73 (0.6911)	57.64 (0.6910)
3 Hours	58.37 (0.6831)	61.21 (0.6911)	58.68 (0.6910)
4 Hours	58.73 (0.6831)	60.74 (0.6911)	58.24 (0.6910)
8 Hours	61.13 (0.6831)	63.40 (0.6911)	61.95 (0.6910)
12 Hours	66.22 (0.6831)	66.60 (0.6911)	66.95 (0.6910)
24 Hours	59.32 (0.6831)	60.23 (0.6911)	62.35 (0.6910)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1600
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.28
	Confidence Interval	(2-Sided) 90% -0.22 to 2.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0092
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.38
	Confidence Interval	(2-Sided) 90% 0.88 to 3.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3174
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 90% -0.59 to 2.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7344
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 90% -1.81 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5881
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 90% -1.00 to 1.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3680
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.82
	Confidence Interval	(2-Sided) 90% -2.32 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4200
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 90% -2.23 to 0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0009
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-3.03
	Confidence Interval	(2-Sided) 90% -4.53 to -1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	4.46
	Confidence Interval	(2-Sided) 90% 2.96 to 5.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	5.83
	Confidence Interval	(2-Sided) 90% 4.32 to 7.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	4.09
	Confidence Interval	(2-Sided) 90% 2.58 to 5.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0059
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.53
	Confidence Interval	(2-Sided) 90% 1.02 to 4.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0063
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.50
	Confidence Interval	(2-Sided) 90% 1.00 to 4.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1138
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 90% -0.06 to 2.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6976
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 90% -1.86 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0208
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.12
	Confidence Interval	(2-Sided) 90% -3.62 to -0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
Description	Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time Frame	0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
0.5 Hour	171.59 (0.9261)	170.52 (0.9361)	172.24 (0.9358)
1 Hour	171.15 (0.9261)	169.28 (0.9361)	172.09 (0.9358)
2 Hours	170.43 (0.9261)	169.72 (0.9361)	171.60 (0.9358)
3 Hours	169.86 (0.9261)	169.34 (0.9361)	170.85 (0.9358)
4 Hours	170.59 (0.9261)	169.22 (0.9361)	171.16 (0.9358)
8 Hours	164.86 (0.9261)	165.25 (0.9361)	167.31 (0.9358)
12 Hours	166.08 (0.9261)	165.48 (0.9361)	166.49 (0.9358)
24 Hours	172.09 (0.9261)	169.50 (0.9361)	171.57 (0.9358)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5760
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 90% -2.53 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4126
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.94
	Confidence Interval	(2-Sided) 90% -2.83 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3085
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.17
	Confidence Interval	(2-Sided) 90% -3.06 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3889
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.99
	Confidence Interval	(2-Sided) 90% -2.88 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6192
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 90% -2.46 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0332
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.45
	Confidence Interval	(2-Sided) 90% -4.34 to -0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7224
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 90% -2.30 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6507
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 90% -1.37 to 2.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1366
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.72
	Confidence Interval	(2-Sided) 90% -3.62 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0153
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.81
	Confidence Interval	(2-Sided) 90% -4.71 to -0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1040
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.88
	Confidence Interval	(2-Sided) 90% -3.78 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1924
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.51
	Confidence Interval	(2-Sided) 90% -3.41 to 0.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0928
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.94
	Confidence Interval	(2-Sided) 90% -3.84 to -0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0745
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.06
	Confidence Interval	(2-Sided) 90% -3.96 to -0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3836
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.01
	Confidence Interval	(2-Sided) 90% -2.91 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0734
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.07
	Confidence Interval	(2-Sided) 90% -3.97 to -0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
Description	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.
Time Frame	0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	43	42	42
0.5 Hour	90.76 (0.5481)	89.28 (0.5547)	89.96 (0.5544)
1 Hour	90.51 (0.5481)	89.18 (0.5547)	90.37 (0.5544)
2 Hours	90.89 (0.5481)	89.14 (0.5547)	89.88 (0.5544)
3 Hours	89.36 (0.5481)	89.31 (0.5547)	89.39 (0.5544)
4 Hours	89.84 (0.5481)	88.95 (0.5547)	91.02 (0.5544)
8 Hours	89.14 (0.5481)	88.22 (0.5547)	88.94 (0.5544)
12 Hours	89.61 (0.5481)	89.09 (0.5547)	89.58 (0.5544)
24 Hours	89.31 (0.5481)	88.61 (0.5547)	89.23 (0.5544)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	PF-04447943 25 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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2588
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 90% -0.36 to 1.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8465
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 90% -1.03 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1502
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 90% -0.15 to 2.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9700
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 90% -1.19 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0947
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.18
	Confidence Interval	(2-Sided) 90% -2.34 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7759
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 90% -0.96 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9649
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 90% -1.13 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Moxifloxacin 400 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9034
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 90% -1.08 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3391
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.68
	Confidence Interval	(2-Sided) 90% -1.85 to 0.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0948
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.19
	Confidence Interval	(2-Sided) 90% -2.35 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2959
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.74
	Confidence Interval	(2-Sided) 90% -1.91 to 0.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9161
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 90% -1.24 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0036
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.07
	Confidence Interval	(2-Sided) 90% -3.24 to -0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3063
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 90% -1.89 to 0.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4918
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 90% -1.65 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3862
	Comments
	Method	Repeated Measures Model
	Comments

Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.61
	Confidence Interval	(2-Sided) 90% -1.78 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Moxifloxacin 400 mg	Placebo
Arm/Group Description	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.	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.	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.	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.
Measure Participants	43	42	41	42
AEs	11 (27) 25%	9 NaN	8 NaN	8 NaN
SAEs	0 0%	0 NaN	0 NaN	0 NaN

14. Secondary Outcome

Title	Number of Participants With Physical Examination Abnormalities
Description	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.
Time Frame	Baseline (Pre-dose)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Moxifloxacin 400 mg	Placebo
Arm/Group Description	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.	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.	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.	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.
Measure Participants	43	42	41	42
Count of Participants [Participants]	1 (27) 2.3%	1 NaN	1 NaN	2 NaN

15. Secondary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities
Description	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.
Time Frame	Baseline up to 24 hours post-dose

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Moxifloxacin 400 mg	Placebo
Arm/Group Description	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.	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.	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.	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.
Measure Participants	43	42	41	42
QTcB Interval 450 to <480 msec	1 (27) 2.3%	3 NaN	1 NaN	0 NaN
QTcB Interval 480 to <500 msec	0 0%	0 NaN	0 NaN	0 NaN
QTcB Interval >=500 msec	0 0%	0 NaN	0 NaN	0 NaN
QTcB IFB (>= 30 to <60) msec	0 0%	1 NaN	2 NaN	1 NaN
QTcB IFB (>=60) msec	0 0%	0 NaN	0 NaN	0 NaN
QTcF Interval 450 to <480 msec	0 0%	1 NaN	1 NaN	0 NaN
QTcF Interval 480 to <500 msec	0 0%	0 NaN	0 NaN	0 NaN
QTcF Interval >=500 msec	0 0%	0 NaN	0 NaN	0 NaN
QTcF IFB (>=30 to <60) msec	0 0%	0 NaN	0 NaN	0 NaN
QTcF IFB (>=60) msec	0 0%	0 NaN	0 NaN	0 NaN

16. Secondary Outcome

Title	Number of Participants With Vital Sign Abnormalities
Description	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.
Time Frame	Baseline (Pre-dose) up to 24 hours post-dose

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least one dose of study medication.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Moxifloxacin 400 mg	Placebo
Arm/Group Description	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.	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.	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.	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.
Measure Participants	43	42	41	42
Supine SBP: <90 mmHg	0 (27) 0%	0 NaN	0 NaN	0 NaN
Standing SBP: <90 mmHg	0 0%	0 NaN	2 NaN	0 NaN
Supine DBP: <50 mmHg	0 0%	0 NaN	1 NaN	0 NaN
Standing DBP: <50 mmHg	0 0%	0 NaN	1 NaN	0 NaN
Supine Pulse Rate: <40 bpm	0 0%	0 NaN	1 NaN	0 NaN
Supine Pulse Rate: >120 bpm	0 0%	0 NaN	0 NaN	0 NaN
Standing Pulse Rate: <40 bpm	0 0%	0 NaN	0 NaN	0 NaN
Standing Pulse Rate: >120 bpm	0 0%	1 NaN	0 NaN	1 NaN
Max. IFB in Supine SBP: >=30mmHg	0 0%	0 NaN	0 NaN	2 NaN
Max. IFB in StandingSBP:>=30 mmHg	1 2.3%	0 NaN	0 NaN	1 NaN
Max. IFB in Supine DBP: >=20 mmHg	0 0%	0 NaN	0 NaN	1 NaN
Max. IFB in StandingDBP:>=20 mmHg	2 4.5%	2 NaN	3 NaN	1 NaN
Max. DFB in Supine SBP:>=30 mmHg	0 0%	0 NaN	0 NaN	0 NaN
Max. DFB in StandingSBP:>=30 mmHg	2 4.5%	1 NaN	1 NaN	3 NaN
Max. DFB in Supine DBP:>=20 mmHg	0 0%	0 NaN	0 NaN	0 NaN
Max. DFB in StandingDBP:>=20 mmHg	2 4.5%	4 NaN	1 NaN	0 NaN

17. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormalities
Description	Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8lower limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9LLN, >1.1upper limit of normal(ULN), platelet<0.5LLN,>1.75ULN, lymphocyte, neutrophil<0.8LLN, >1.2ULN, basophil, eosinophil, monocyte>1.2ULN, white blood cell(WBC)<0.6LLN,>1.5ULN, reticulocytes<0.5LLN,>1.5ULN; bilirubin>1.5ULN, aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0ULN, protein, albumin<0.8LLN,>1.2ULN; blood urea nitrogen, creatinine>1.3ULN, uric acid>1.2ULN; sodium<0.95LLN,>1.05ULN, potassium, chloride, calcium, bicarbonate<0.9LLN,>1.1ULN; glucose<0.6LLN, >1.5ULN, HbA1c>1.3ULN, creatinine kinase>2ULN; 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<0.8LLN,>1.2ULN; cholesterol, triglycerides>1.3ULN, high density lipoprotein cholesterol(DL-C) <0.8LLN, low DL-C>1.2*ULN.
Time Frame	Baseline (Pre-dose) up to 24 hours post-dose

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg	Moxifloxacin 400 mg	Placebo
Arm/Group Description	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.	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.	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.	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.
Measure Participants	43	42	41	42
Count of Participants [Participants]	17 (27) 38.6%	12 NaN	12 NaN	18 NaN

18. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of PF-04447943
Description
Time Frame	Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg
Arm/Group Description	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.	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.
Measure Participants	43	42
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	225.8 (19)	947.3 (17)

19. Secondary Outcome

Title	Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
Description
Time Frame	Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description
PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg
Arm/Group Description	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.	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.
Measure Participants	43	42
Median (Full Range) [Hours]	1.0 (27)	1.02

20. Secondary Outcome

Title	Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
Description	Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.
Time Frame	Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description
PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest.

Arm/Group Title	PF-04447943 25 mg	PF-04447943 100 mg
Arm/Group Description	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.	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.
Measure Participants	43	42
Geometric Mean (Geometric Coefficient of Variation) [Nanogram*hour per milliliter]	1454 (27)	6277 (24)

Adverse Events

	PF-04447943 25 mg		PF-04447943 100 mg		Moxifloxacin 400 mg		Placebo
Time Frame	Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Adverse Event Reporting Description	Safety population included all participants who received at least 1 dose of study medication.

Arm/Group Title	PF-04447943 25 mg		PF-04447943 100 mg		Moxifloxacin 400 mg		Placebo
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)		0/41 (0%)		0/42 (0%)
Serious Adverse Events
	PF-04447943 25 mg		PF-04447943 100 mg		Moxifloxacin 400 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)		0/41 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	PF-04447943 25 mg		PF-04447943 100 mg		Moxifloxacin 400 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/43 (16.3%)		3/42 (7.1%)		3/41 (7.3%)		2/42 (4.8%)
Gastrointestinal disorders
Nausea	4/43 (9.3%)		3/42 (7.1%)		1/41 (2.4%)		1/42 (2.4%)
Nervous system disorders
Headache	3/43 (7%)		2/42 (4.8%)		2/41 (4.9%)		1/42 (2.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02785770

Other Study ID Numbers:

B0401018

First Posted:

May 30, 2016

Last Update Posted:

Dec 28, 2018

Last Verified:

Jun 1, 2018