Trial Outcomes & Findings for A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects (NCT NCT02785770)
NCT ID: NCT02785770
Last Updated: 2018-12-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
0.5 hour post-dose
Results posted on
2018-12-28
Participant Flow
Participant milestones
| Measure |
Moxifloxacin, Placebo, PF-04447943 100 mg, PF-04447943 25 mg
Participants received a single oral dose of Moxifloxacin 400 milligram (mg) tablet on Day 1 in the first intervention period; followed by a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
PF-04447943 25 mg, Moxifloxacin, Placebo, PF-04447943 100 mg
Participants received a single dose of oral solution of PF-04447943 25 mg on Day 1 in the first intervention period; followed by a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the second intervention period; then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
Placebo, PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 100 mg on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the third intervention period; and then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin, Placebo
Participants received a single dose of oral solution of PF-04447943 100 mg on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 25 mg on Day 1 in the second intervention period; then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the third intervention period; and then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Washout Period 1 (7 Days)
COMPLETED
|
11
|
11
|
11
|
11
|
|
Washout Period 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Period 1 (1 Day)
STARTED
|
11
|
11
|
11
|
11
|
|
Intervention Period 1 (1 Day)
COMPLETED
|
11
|
11
|
11
|
11
|
|
Intervention Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (7 Days)
STARTED
|
11
|
11
|
11
|
11
|
|
Intervention Period 2 (1 Day)
STARTED
|
11
|
11
|
11
|
11
|
|
Intervention Period 2 (1 Day)
COMPLETED
|
11
|
10
|
10
|
11
|
|
Intervention Period 2 (1 Day)
NOT COMPLETED
|
0
|
1
|
1
|
0
|
|
Washout Period 2 (7 Days)
STARTED
|
11
|
10
|
10
|
11
|
|
Washout Period 2 (7 Days)
COMPLETED
|
11
|
10
|
10
|
11
|
|
Washout Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Period 3 (1 Day)
STARTED
|
11
|
10
|
10
|
11
|
|
Intervention Period 3 (1 Day)
COMPLETED
|
11
|
10
|
10
|
10
|
|
Intervention Period 3 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Washout Period 3 (7 Days)
STARTED
|
11
|
10
|
10
|
10
|
|
Washout Period 3 (7 Days)
COMPLETED
|
11
|
10
|
10
|
10
|
|
Washout Period 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention Period 4 (1 Day)
STARTED
|
11
|
10
|
10
|
10
|
|
Intervention Period 4 (1 Day)
COMPLETED
|
11
|
10
|
10
|
10
|
|
Intervention Period 4 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Moxifloxacin, Placebo, PF-04447943 100 mg, PF-04447943 25 mg
Participants received a single oral dose of Moxifloxacin 400 milligram (mg) tablet on Day 1 in the first intervention period; followed by a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
PF-04447943 25 mg, Moxifloxacin, Placebo, PF-04447943 100 mg
Participants received a single dose of oral solution of PF-04447943 25 mg on Day 1 in the first intervention period; followed by a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the second intervention period; then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the third intervention period; and then a single dose of oral solution of PF-04447943 100 mg on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
Placebo, PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 100 mg on Day 1 in the second intervention period; then a single dose of oral solution of PF-04447943 25 mg on Day 1 in the third intervention period; and then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
PF-04447943 100 mg, PF-04447943 25 mg, Moxifloxacin, Placebo
Participants received a single dose of oral solution of PF-04447943 100 mg on Day 1 in the first intervention period; followed by a single dose of oral solution of PF-04447943 25 mg on Day 1 in the second intervention period; then a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in the third intervention period; and then a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in the fourth intervention period. A washout period of at least 7 days was maintained between each intervention period. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Intervention Period 2 (1 Day)
Adverse Event
|
0
|
1
|
0
|
0
|
|
Intervention Period 2 (1 Day)
Family related obligations
|
0
|
0
|
1
|
0
|
|
Intervention Period 3 (1 Day)
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Overall Study
n=44 Participants
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.
|
|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0.5 hour post-dosePopulation: Electrocardiogram (ECG) analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
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
|
404.09 Millisecond (Msec)
Standard Error 0.9544
|
408.92 Millisecond (Msec)
Standard Error 0.9659
|
404.38 Millisecond (Msec)
Standard Error 0.9653
|
—
|
PRIMARY outcome
Timeframe: 1 hour post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
|
404.23 Msec
Standard Error 0.9544
|
409.14 Msec
Standard Error 0.965
|
404.09 Msec
Standard Error 0.9653
|
—
|
PRIMARY outcome
Timeframe: 2 hours post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
|
403.76 Msec
Standard Error 0.9544
|
406.78 Msec
Standard Error 0.9659
|
402.52 Msec
Standard Error 0.9653
|
—
|
PRIMARY outcome
Timeframe: 3 hours post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
|
403.95 Msec
Standard Error 0.9544
|
406.69 Msec
Standard Error 0.9659
|
404.43 Msec
Standard Error 0.9653
|
—
|
PRIMARY outcome
Timeframe: 4 hours post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
|
402.76 Msec
Standard Error 0.9544
|
405.94 Msec
Standard Error 0.9659
|
404.73 Msec
Standard Error 0.9653
|
—
|
PRIMARY outcome
Timeframe: 8 hours post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
|
397.31 Msec
Standard Error 0.9544
|
398.55 Msec
Standard Error 0.9659
|
398.66 Msec
Standard Error 0.9653
|
—
|
PRIMARY outcome
Timeframe: 12 hours post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
|
399.83 Msec
Standard Error 0.9544
|
399.38 Msec
Standard Error 0.9659
|
401.99 Msec
Standard Error 0.9653
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
|
401.72 Msec
Standard Error 0.9544
|
400.28 Msec
Standard Error 0.9659
|
403.06 Msec
Standard Error 0.9653
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dosePopulation: ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=41 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
0.5 Hour
|
405.34 Msec
Standard Error 0.9765
|
404.38 Msec
Standard Error 0.9653
|
—
|
—
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
1 Hour
|
411.98 Msec
Standard Error 0.9765
|
404.09 Msec
Standard Error 0.9653
|
—
|
—
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
2 Hours
|
413.85 Msec
Standard Error 0.9765
|
402.52 Msec
Standard Error 0.9653
|
—
|
—
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
3 Hours
|
413.03 Msec
Standard Error 0.9765
|
404.43 Msec
Standard Error 0.9653
|
—
|
—
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
4 Hours
|
413.69 Msec
Standard Error 0.9765
|
404.73 Msec
Standard Error 0.9653
|
—
|
—
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
8 Hours
|
406.72 Msec
Standard Error 0.9765
|
398.66 Msec
Standard Error 0.9653
|
—
|
—
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
12 Hours
|
407.52 Msec
Standard Error 0.9765
|
401.99 Msec
Standard Error 0.9653
|
—
|
—
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
24 Hours
|
406.81 Msec
Standard Error 0.9765
|
403.06 Msec
Standard Error 0.9653
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
0.5 Hour
|
60.72 Beats per minute (bpm)
Standard Error 0.6831
|
63.91 Beats per minute (bpm)
Standard Error 0.6911
|
59.44 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
1 Hour
|
60.98 Beats per minute (bpm)
Standard Error 0.6831
|
64.43 Beats per minute (bpm)
Standard Error 0.6911
|
58.60 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
2 Hours
|
58.55 Beats per minute (bpm)
Standard Error 0.6831
|
61.73 Beats per minute (bpm)
Standard Error 0.6911
|
57.64 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
3 Hours
|
58.37 Beats per minute (bpm)
Standard Error 0.6831
|
61.21 Beats per minute (bpm)
Standard Error 0.6911
|
58.68 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
4 Hours
|
58.73 Beats per minute (bpm)
Standard Error 0.6831
|
60.74 Beats per minute (bpm)
Standard Error 0.6911
|
58.24 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
8 Hours
|
61.13 Beats per minute (bpm)
Standard Error 0.6831
|
63.40 Beats per minute (bpm)
Standard Error 0.6911
|
61.95 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
12 Hours
|
66.22 Beats per minute (bpm)
Standard Error 0.6831
|
66.60 Beats per minute (bpm)
Standard Error 0.6911
|
66.95 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
|
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
24 Hours
|
59.32 Beats per minute (bpm)
Standard Error 0.6831
|
60.23 Beats per minute (bpm)
Standard Error 0.6911
|
62.35 Beats per minute (bpm)
Standard Error 0.6910
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
0.5 Hour
|
171.59 Msec
Standard Error 0.9261
|
170.52 Msec
Standard Error 0.9361
|
172.24 Msec
Standard Error 0.9358
|
—
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
1 Hour
|
171.15 Msec
Standard Error 0.9261
|
169.28 Msec
Standard Error 0.9361
|
172.09 Msec
Standard Error 0.9358
|
—
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
2 Hours
|
170.43 Msec
Standard Error 0.9261
|
169.72 Msec
Standard Error 0.9361
|
171.60 Msec
Standard Error 0.9358
|
—
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
3 Hours
|
169.86 Msec
Standard Error 0.9261
|
169.34 Msec
Standard Error 0.9361
|
170.85 Msec
Standard Error 0.9358
|
—
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
4 Hours
|
170.59 Msec
Standard Error 0.9261
|
169.22 Msec
Standard Error 0.9361
|
171.16 Msec
Standard Error 0.9358
|
—
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
8 Hours
|
164.86 Msec
Standard Error 0.9261
|
165.25 Msec
Standard Error 0.9361
|
167.31 Msec
Standard Error 0.9358
|
—
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
12 Hours
|
166.08 Msec
Standard Error 0.9261
|
165.48 Msec
Standard Error 0.9361
|
166.49 Msec
Standard Error 0.9358
|
—
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
24 Hours
|
172.09 Msec
Standard Error 0.9261
|
169.50 Msec
Standard Error 0.9361
|
171.57 Msec
Standard Error 0.9358
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=42 Participants
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.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
2 Hours
|
90.89 Msec
Standard Error 0.5481
|
89.14 Msec
Standard Error 0.5547
|
89.88 Msec
Standard Error 0.5544
|
—
|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
0.5 Hour
|
90.76 Msec
Standard Error 0.5481
|
89.28 Msec
Standard Error 0.5547
|
89.96 Msec
Standard Error 0.5544
|
—
|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
1 Hour
|
90.51 Msec
Standard Error 0.5481
|
89.18 Msec
Standard Error 0.5547
|
90.37 Msec
Standard Error 0.5544
|
—
|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
3 Hours
|
89.36 Msec
Standard Error 0.5481
|
89.31 Msec
Standard Error 0.5547
|
89.39 Msec
Standard Error 0.5544
|
—
|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
4 Hours
|
89.84 Msec
Standard Error 0.5481
|
88.95 Msec
Standard Error 0.5547
|
91.02 Msec
Standard Error 0.5544
|
—
|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
8 Hours
|
89.14 Msec
Standard Error 0.5481
|
88.22 Msec
Standard Error 0.5547
|
88.94 Msec
Standard Error 0.5544
|
—
|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
12 Hours
|
89.61 Msec
Standard Error 0.5481
|
89.09 Msec
Standard Error 0.5547
|
89.58 Msec
Standard Error 0.5544
|
—
|
|
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
24 Hours
|
89.31 Msec
Standard Error 0.5481
|
88.61 Msec
Standard Error 0.5547
|
89.23 Msec
Standard Error 0.5544
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=41 Participants
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.
|
Placebo
n=42 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
11 Participants
27 • Interval -0.36 to 1.96
|
9 Participants
Interval -1.85 to 0.49
|
8 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
Interval -1.03 to 1.3
|
0 Participants
Interval -2.35 to -0.02
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose)Population: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=41 Participants
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.
|
Placebo
n=42 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Physical Examination Abnormalities
|
1 Participants
27 • Interval -0.36 to 1.96
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 hours post-dosePopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=41 Participants
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.
|
Placebo
n=42 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcB Interval 450 to <480 msec
|
1 Participants
27 • Interval -0.36 to 1.96
|
3 Participants
Interval -1.85 to 0.49
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcB Interval 480 to <500 msec
|
0 Participants
Interval -1.03 to 1.3
|
0 Participants
Interval -2.35 to -0.02
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcB Interval >=500 msec
|
0 Participants
Interval -0.15 to 2.18
|
0 Participants
Interval -1.91 to 0.43
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcB IFB (>= 30 to <60) msec
|
0 Participants
Interval -1.19 to 1.14
|
1 Participants
Interval -1.24 to 1.09
|
2 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcB IFB (>=60) msec
|
0 Participants
Interval -2.34 to -0.02
|
0 Participants
Interval -3.24 to -0.91
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcF Interval 450 to <480 msec
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcF Interval 480 to <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcF Interval >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcF IFB (>=30 to <60) msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
QTcF IFB (>=60) msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) up to 24 hours post-dosePopulation: Safety analysis set included all participants who received at least one dose of study medication.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=41 Participants
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.
|
Placebo
n=42 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities
Standing Pulse Rate: >120 bpm
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in Supine SBP: >=30mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in StandingSBP:>=30 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in Supine DBP: >=20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in StandingDBP:>=20 mmHg
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Supine SBP: <90 mmHg
|
0 Participants
27 • Interval -0.36 to 1.96
|
0 Participants
Interval -1.85 to 0.49
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in Supine DBP:>=20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Supine Pulse Rate: >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Standing Pulse Rate: <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Standing SBP: <90 mmHg
|
0 Participants
Interval -1.03 to 1.3
|
0 Participants
Interval -2.35 to -0.02
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Supine DBP: <50 mmHg
|
0 Participants
Interval -0.15 to 2.18
|
0 Participants
Interval -1.91 to 0.43
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Standing DBP: <50 mmHg
|
0 Participants
Interval -1.19 to 1.14
|
0 Participants
Interval -1.24 to 1.09
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Supine Pulse Rate: <40 bpm
|
0 Participants
Interval -2.34 to -0.02
|
0 Participants
Interval -3.24 to -0.91
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in Supine SBP:>=30 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in StandingSBP:>=30 mmHg
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in StandingDBP:>=20 mmHg
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose) up to 24 hours post-dosePopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
n=41 Participants
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.
|
Placebo
n=42 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
17 Participants
27 • Interval -0.36 to 1.96
|
12 Participants
Interval -1.85 to 0.49
|
12 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dosePopulation: 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.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-04447943
|
225.8 Nanogram per milliliter
Geometric Coefficient of Variation 19 • Interval -0.36 to 1.96
|
947.3 Nanogram per milliliter
Geometric Coefficient of Variation 17 • Interval -1.85 to 0.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dosePopulation: PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
|
1.0 Hours
Full Range 27 • Interval 0.5 to 3.0
|
1.02 Hours
Interval 0.5 to 3.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dosePopulation: PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest.
Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.
Outcome measures
| Measure |
PF-04447943 25 mg
n=43 Participants
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.
|
PF-04447943 100 mg
n=42 Participants
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.
|
Moxifloxacin 400 mg
Participants received a single oral dose of Moxifloxacin 400 mg tablet on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
Placebo
Participants received a single dose of oral solution of placebo matched to PF-04447943 on Day 1 in any of the 4 intervention periods. Participants were followed up to 28 days after last dose of study medication.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
|
1454 Nanogram*hour per milliliter
Geometric Coefficient of Variation 27 • Interval -0.36 to 1.96
|
6277 Nanogram*hour per milliliter
Geometric Coefficient of Variation 24 • Interval -1.85 to 0.49
|
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Adverse Events
PF-04447943 25 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-04447943 100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moxifloxacin 400 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-04447943 25 mg
n=43 participants at risk
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.
|
PF-04447943 100 mg
n=42 participants at risk
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.
|
Moxifloxacin 400 mg
n=41 participants at risk
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.
|
Placebo
n=42 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.3%
4/43 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
7.1%
3/42 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
2.4%
1/41 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
2.4%
1/42 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
7.0%
3/43 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
4.8%
2/42 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
4.9%
2/41 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
2.4%
1/42 • Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Safety population included all participants who received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER