Trial Outcomes & Findings for Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis (NCT NCT01736696)
NCT ID: NCT01736696
Last Updated: 2013-02-20
Results Overview
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1
Results posted on
2013-02-20
Participant Flow
Participant milestones
| Measure |
CP-690,550 5 mg (Cohort 1)
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
10
|
9
|
9
|
8
|
13
|
|
Overall Study
COMPLETED
|
5
|
5
|
9
|
9
|
9
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
CP-690,550 5 mg (Cohort 1)
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis
Baseline characteristics by cohort
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
40.2 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
46.9 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
47.1 years
STANDARD_DEVIATION 9.7 • n=8 Participants
|
44.4 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
43.9 years
STANDARD_DEVIATION 10.3 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1Population: Analysis population included all participants who met the eligibility criteria.
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1
Baseline for HPD 1
|
372.20 millisecond (msec)
Standard Deviation 34.3
|
348.47 millisecond (msec)
Standard Deviation 23.52
|
369.40 millisecond (msec)
Standard Deviation 19.47
|
375.74 millisecond (msec)
Standard Deviation 24.65
|
383.96 millisecond (msec)
Standard Deviation 18.10
|
371.29 millisecond (msec)
Standard Deviation 28.33
|
370.95 millisecond (msec)
Standard Deviation 18.00
|
|
Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1
Change at HPD 1 on Day 1
|
-6.33 millisecond (msec)
Standard Deviation 25.91
|
15.73 millisecond (msec)
Standard Deviation 9.04
|
-6.33 millisecond (msec)
Standard Deviation 21.67
|
2.70 millisecond (msec)
Standard Deviation 14.54
|
1.63 millisecond (msec)
Standard Deviation 14.09
|
-2.79 millisecond (msec)
Standard Deviation 13.28
|
-4.21 millisecond (msec)
Standard Deviation 12.61
|
PRIMARY outcome
Timeframe: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1Population: Analysis population included all participants who met the eligibility criteria.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1
Baseline for HPD 2
|
369.67 msec
Standard Deviation 33.78
|
350.27 msec
Standard Deviation 20.76
|
372.87 msec
Standard Deviation 21.10
|
377.48 msec
Standard Deviation 24.26
|
387.00 msec
Standard Deviation 18.81
|
374.00 msec
Standard Deviation 26.75
|
369.87 msec
Standard Deviation 17.53
|
|
Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1
Change at HPD 2 on Day 1
|
-0.40 msec
Standard Deviation 26.39
|
9.80 msec
Standard Deviation 13.71
|
-6.90 msec
Standard Deviation 22.22
|
-0.15 msec
Standard Deviation 12.82
|
-0.07 msec
Standard Deviation 9.40
|
-1.58 msec
Standard Deviation 13.66
|
-2.05 msec
Standard Deviation 16.76
|
PRIMARY outcome
Timeframe: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1Population: Analysis population included all participants who met the eligibility criteria. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1
Change at HPD 4 on Day 1 (n=5,5,9,9,9,8,13)
|
-4.53 msec
Standard Deviation 23.17
|
11.53 msec
Standard Deviation 12.32
|
2.19 msec
Standard Deviation 20.98
|
2.96 msec
Standard Deviation 17.94
|
7.74 msec
Standard Deviation 14.69
|
-8.17 msec
Standard Deviation 14.32
|
-2.82 msec
Standard Deviation 10.82
|
|
Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1
Baseline for HPD 4 (n=5,5,10,9,9,8,13)
|
373.73 msec
Standard Deviation 31.71
|
348.07 msec
Standard Deviation 23.34
|
373.20 msec
Standard Deviation 21.78
|
373.15 msec
Standard Deviation 20.46
|
381.44 msec
Standard Deviation 20.02
|
381.17 msec
Standard Deviation 26.96
|
368.00 msec
Standard Deviation 18.04
|
PRIMARY outcome
Timeframe: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1Population: Analysis population included all participants who met the eligibility criteria. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1
Baseline for HPD 8 (n=5,5,10,9,9,8,13)
|
364.13 msec
Standard Deviation 36.00
|
356.73 msec
Standard Deviation 25.62
|
366.90 msec
Standard Deviation 22.02
|
374.56 msec
Standard Deviation 22.73
|
378.15 msec
Standard Deviation 23.91
|
372.25 msec
Standard Deviation 28.29
|
367.56 msec
Standard Deviation 17.95
|
|
Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1
Change at HPD 8 on Day 1 (n=5,5,9,9,9,8,13)
|
-1.27 msec
Standard Deviation 15.93
|
-6.60 msec
Standard Deviation 10.71
|
-3.96 msec
Standard Deviation 18.54
|
-3.44 msec
Standard Deviation 12.75
|
7.67 msec
Standard Deviation 16.08
|
-9.83 msec
Standard Deviation 15.12
|
-9.03 msec
Standard Deviation 11.52
|
PRIMARY outcome
Timeframe: 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1Population: Analysis population included all participants who met the eligibility criteria. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1
Baseline for HPD 12 (n=5,5,10,9,9,8,13)
|
371.73 msec
Standard Deviation 31.50
|
351.27 msec
Standard Deviation 22.90
|
372.63 msec
Standard Deviation 22.54
|
370.11 msec
Standard Deviation 25.70
|
379.78 msec
Standard Deviation 24.93
|
363.08 msec
Standard Deviation 31.21
|
361.54 msec
Standard Deviation 16.29
|
|
Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1
Change at HPD 12 on Day 1 (n=5,5,9,9,9,8,13)
|
-6.27 msec
Standard Deviation 19.05
|
-2.60 msec
Standard Deviation 5.27
|
-4.15 msec
Standard Deviation 17.90
|
0.15 msec
Standard Deviation 9.79
|
-3.22 msec
Standard Deviation 19.73
|
-2.88 msec
Standard Deviation 14.01
|
-1.36 msec
Standard Deviation 13.60
|
PRIMARY outcome
Timeframe: 8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=9 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=3 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1
Baseline for HPD 16
|
377.15 msec
Standard Deviation 19.50
|
345.44 msec
Standard Deviation 18.77
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1
Change at HPD 16 on Day 1
|
11.19 msec
Standard Deviation 19.98
|
13.11 msec
Standard Deviation 7.26
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14Population: Analysis population included all participants who met the eligibility criteria.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14
Baseline for HPD 0
|
374.80 msec
Standard Deviation 28.95
|
360.40 msec
Standard Deviation 28.03
|
367.70 msec
Standard Deviation 30.28
|
372.81 msec
Standard Deviation 27.83
|
383.41 msec
Standard Deviation 19.25
|
367.50 msec
Standard Deviation 22.12
|
364.03 msec
Standard Deviation 20.96
|
|
Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14
Change at HPD 0 on Day 14
|
-14.53 msec
Standard Deviation 11.39
|
11.00 msec
Standard Deviation 12.00
|
-0.33 msec
Standard Deviation 14.08
|
7.22 msec
Standard Deviation 16.38
|
-9.70 msec
Standard Deviation 13.15
|
-0.79 msec
Standard Deviation 17.48
|
-7.08 msec
Standard Deviation 16.21
|
PRIMARY outcome
Timeframe: 23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14
|
-8.87 msec
Standard Deviation 12.12
|
22.27 msec
Standard Deviation 13.72
|
0.11 msec
Standard Deviation 12.55
|
2.81 msec
Standard Deviation 15.98
|
-0.96 msec
Standard Deviation 14.63
|
0.71 msec
Standard Deviation 20.43
|
-12.87 msec
Standard Deviation 17.82
|
PRIMARY outcome
Timeframe: 22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14Population: Analysis population included all participants who met the eligibility criteria.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14
|
-3.80 msec
Standard Deviation 12.18
|
18.67 msec
Standard Deviation 11.15
|
-3.93 msec
Standard Deviation 13.21
|
6.89 msec
Standard Deviation 13.98
|
-3.81 msec
Standard Deviation 17.18
|
2.46 msec
Standard Deviation 22.04
|
-12.28 msec
Standard Deviation 19.35
|
PRIMARY outcome
Timeframe: 20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14
|
-13.80 msec
Standard Deviation 15.37
|
6.53 msec
Standard Deviation 7.81
|
-8.41 msec
Standard Deviation 7.25
|
18.96 msec
Standard Deviation 18.55
|
9.59 msec
Standard Deviation 10.70
|
-4.79 msec
Standard Deviation 21.58
|
-8.46 msec
Standard Deviation 21.09
|
PRIMARY outcome
Timeframe: 16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14
|
-9.33 msec
Standard Deviation 11.31
|
-0.53 msec
Standard Deviation 9.83
|
-6.15 msec
Standard Deviation 15.86
|
-1.96 msec
Standard Deviation 13.75
|
4.85 msec
Standard Deviation 18.51
|
-2.67 msec
Standard Deviation 23.28
|
-12.36 msec
Standard Deviation 11.38
|
PRIMARY outcome
Timeframe: 12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14
|
-13.47 msec
Standard Deviation 12.76
|
8.00 msec
Standard Deviation 8.48
|
-10.52 msec
Standard Deviation 10.63
|
0.81 msec
Standard Deviation 13.99
|
-7.44 msec
Standard Deviation 22.73
|
-0.63 msec
Standard Deviation 23.46
|
-4.82 msec
Standard Deviation 15.31
|
PRIMARY outcome
Timeframe: 1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21Population: Analysis population included all participants who met the eligibility criteria.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (\<) 60 msec(borderline) and greater than or equal to (\>=) 60 msec (prolonged) were summarized.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval
QTcB,Maximum increase from baseline:30 to <60msec
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval
QTcB,Maximum increase from baseline:>=60msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval
QTcF,Maximum increase from baseline:30 to <60msec
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval
QTcF,Maximum increase from baseline:>=60msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21Population: Analysis population included all participants who met the eligibility criteria.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum QTc \>=500 msec were reported.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond
QTcF
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond
QTcB
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
AUCtau = area under the curve from time zero to end of dosing interval.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=9 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1
|
161 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 86.1
|
349 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 34.7
|
732 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 232
|
860 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 235
|
2120 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 837
|
1720 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 453
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
AUCtau = area under the curve from time zero to end of dosing interval.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=4 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14
|
154 ng*hr/mL
Standard Deviation 80.3
|
422 ng*hr/mL
Standard Deviation 49.5
|
850 ng*hr/mL
Standard Deviation 216
|
1350 ng*hr/mL
Standard Deviation 308
|
2600 ng*hr/mL
Standard Deviation 1580
|
1780 ng*hr/mL
Standard Deviation 501
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=9 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) at Day 1
|
48.3 nanogram/milliliter (ng/mL)
Standard Deviation 24.5
|
90.5 nanogram/milliliter (ng/mL)
Standard Deviation 20.4
|
212 nanogram/milliliter (ng/mL)
Standard Deviation 62.3
|
180 nanogram/milliliter (ng/mL)
Standard Deviation 53.1
|
457 nanogram/milliliter (ng/mL)
Standard Deviation 88.2
|
429 nanogram/milliliter (ng/mL)
Standard Deviation 99.1
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=4 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) at Day 14
|
50.9 ng/mL
Standard Deviation 21.2
|
87.7 ng/mL
Standard Deviation 13.2
|
194 ng/mL
Standard Deviation 53.9
|
225 ng/mL
Standard Deviation 43.9
|
568 ng/mL
Standard Deviation 205
|
403 ng/mL
Standard Deviation 133
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=9 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1
|
0.50 hr
Interval 0.25 to 1.0
|
0.50 hr
Interval 0.5 to 1.0
|
0.50 hr
Interval 0.25 to 2.0
|
0.50 hr
Interval 0.5 to 3.0
|
1.00 hr
Interval 0.5 to 3.0
|
1.00 hr
Interval 0.5 to 2.0
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=4 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14
|
0.50 hr
Interval 0.5 to 0.5
|
1.00 hr
Interval 0.5 to 1.0
|
0.50 hr
Interval 0.25 to 2.0
|
1.00 hr
Interval 0.5 to 4.0
|
1.00 hr
Interval 0.5 to 2.0
|
1.00 hr
Interval 0.5 to 2.0
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14Population: Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=4 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (R0)
|
0.974 Ratio
Standard Deviation 0.181
|
1.22 Ratio
Standard Deviation 0.203
|
1.22 Ratio
Standard Deviation 0.389
|
1.62 Ratio
Standard Deviation 0.343
|
1.16 Ratio
Standard Deviation 0.270
|
1.14 Ratio
Standard Deviation 0.176
|
—
|
PRIMARY outcome
Timeframe: Baseline, 1 hr post-dose on Day 1Population: Analysis population included all participants who met the eligibility criteria.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1
Change at Day 1: CD3
|
-14.39 percent change
Standard Deviation 14.6
|
12.02 percent change
Standard Deviation 18.2
|
1.17 percent change
Standard Deviation 17.7
|
12.44 percent change
Standard Deviation 17.4
|
8.38 percent change
Standard Deviation 23.9
|
12.83 percent change
Standard Deviation 14.0
|
0.52 percent change
Standard Deviation 16.5
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1
Change at Day 1: CD4
|
-18.48 percent change
Standard Deviation 19.4
|
8.65 percent change
Standard Deviation 23.5
|
-4.29 percent change
Standard Deviation 15.2
|
5.99 percent change
Standard Deviation 15.6
|
-1.13 percent change
Standard Deviation 19.9
|
8.54 percent change
Standard Deviation 10.7
|
1.35 percent change
Standard Deviation 18.3
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1
Change at Day 1: CD8
|
-7.58 percent change
Standard Deviation 11.0
|
26.05 percent change
Standard Deviation 25.1
|
8.90 percent change
Standard Deviation 22.1
|
18.34 percent change
Standard Deviation 21.4
|
13.90 percent change
Standard Deviation 21.9
|
25.44 percent change
Standard Deviation 14.6
|
0.42 percent change
Standard Deviation 16.5
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1
Change at Day 1: CD16/56
|
11.22 percent change
Standard Deviation 27.0
|
79.99 percent change
Standard Deviation 33.7
|
81.44 percent change
Standard Deviation 62.7
|
74.07 percent change
Standard Deviation 38.6
|
104.44 percent change
Standard Deviation 85.8
|
103.74 percent change
Standard Deviation 21.2
|
-9.72 percent change
Standard Deviation 18.3
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1
Change at Day 1: CD19
|
-27.11 percent change
Standard Deviation 16.7
|
-4.02 percent change
Standard Deviation 30.9
|
-10.30 percent change
Standard Deviation 18.1
|
-8.23 percent change
Standard Deviation 10.4
|
-6.22 percent change
Standard Deviation 29.9
|
-0.66 percent change
Standard Deviation 9.0
|
-6.46 percent change
Standard Deviation 22.4
|
PRIMARY outcome
Timeframe: Baseline, hr 0 on Day 2Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2
Change at Day 2: CD3
|
8.88 percent change
Standard Deviation 24.0
|
34.74 percent change
Standard Deviation 27.4
|
23.93 percent change
Standard Deviation 31.1
|
46.07 percent change
Standard Deviation 31.4
|
14.05 percent change
Standard Deviation 24.4
|
52.43 percent change
Standard Deviation 34.3
|
-5.18 percent change
Standard Deviation 17.4
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2
Change at Day 2: CD4
|
8.58 percent change
Standard Deviation 26.7
|
33.29 percent change
Standard Deviation 25.4
|
26.73 percent change
Standard Deviation 31.9
|
44.17 percent change
Standard Deviation 33.9
|
18.85 percent change
Standard Deviation 34.9
|
55.80 percent change
Standard Deviation 35.5
|
-6.85 percent change
Standard Deviation 18.0
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2
Change at Day 2: CD8
|
12.67 percent change
Standard Deviation 19.3
|
32.68 percent change
Standard Deviation 30.1
|
19.68 percent change
Standard Deviation 29.3
|
43.04 percent change
Standard Deviation 29.1
|
16.96 percent change
Standard Deviation 25.1
|
50.97 percent change
Standard Deviation 30.4
|
-4.17 percent change
Standard Deviation 20.2
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2
Change at Day 2: CD16/56
|
18.27 percent change
Standard Deviation 30.4
|
61.26 percent change
Standard Deviation 47.8
|
52.84 percent change
Standard Deviation 54.8
|
63.21 percent change
Standard Deviation 45.1
|
0.61 percent change
Standard Deviation 37.7
|
103.79 percent change
Standard Deviation 45.8
|
5.61 percent change
Standard Deviation 35.7
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2
Change at Day 2: CD19
|
7.58 percent change
Standard Deviation 40.3
|
9.56 percent change
Standard Deviation 30.5
|
17.40 percent change
Standard Deviation 24.5
|
30.39 percent change
Standard Deviation 11.3
|
7.04 percent change
Standard Deviation 33.5
|
45.72 percent change
Standard Deviation 44.4
|
-4.22 percent change
Standard Deviation 24.4
|
PRIMARY outcome
Timeframe: Baseline, hr 0 on Day 4Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=4 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4
Change at Day 4: CD19
|
-12.59 percent change
Standard Deviation 27.2
|
41.44 percent change
Standard Deviation 18.2
|
53.84 percent change
Standard Deviation 71.8
|
56.27 percent change
Standard Deviation 35.1
|
44.76 percent change
Standard Deviation 55.7
|
77.25 percent change
Standard Deviation 50.7
|
-2.55 percent change
Standard Deviation 37.5
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4
Change at Day 4: CD16/56
|
-23.08 percent change
Standard Deviation 22.5
|
90.73 percent change
Standard Deviation 41.6
|
10.67 percent change
Standard Deviation 44.3
|
24.27 percent change
Standard Deviation 55.5
|
-5.23 percent change
Standard Deviation 43.2
|
-1.66 percent change
Standard Deviation 44.8
|
7.18 percent change
Standard Deviation 59.8
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4
Change at Day 4: CD3
|
-15.29 percent change
Standard Deviation 21.1
|
51.71 percent change
Standard Deviation 31.4
|
29.11 percent change
Standard Deviation 49.0
|
71.55 percent change
Standard Deviation 44.5
|
34.28 percent change
Standard Deviation 41.8
|
32.81 percent change
Standard Deviation 28.0
|
3.80 percent change
Standard Deviation 28.2
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4
Change at Day 4: CD4
|
-15.87 percent change
Standard Deviation 22.4
|
43.87 percent change
Standard Deviation 22.0
|
30.90 percent change
Standard Deviation 51.7
|
72.02 percent change
Standard Deviation 43.1
|
42.50 percent change
Standard Deviation 56.7
|
39.46 percent change
Standard Deviation 27.2
|
6.08 percent change
Standard Deviation 31.3
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4
Change at Day 4: CD8
|
-10.94 percent change
Standard Deviation 17.8
|
56.72 percent change
Standard Deviation 43.5
|
18.18 percent change
Standard Deviation 41.7
|
61.61 percent change
Standard Deviation 41.4
|
31.95 percent change
Standard Deviation 32.6
|
29.81 percent change
Standard Deviation 33.5
|
-0.31 percent change
Standard Deviation 24.8
|
PRIMARY outcome
Timeframe: Baseline, hr 0 on Day 7Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7
Change at Day 7: CD3
|
5.72 percent change
Standard Deviation 20.6
|
28.15 percent change
Standard Deviation 26.0
|
13.47 percent change
Standard Deviation 55.4
|
25.51 percent change
Standard Deviation 38.9
|
1.61 percent change
Standard Deviation 26.0
|
34.77 percent change
Standard Deviation 33.1
|
-3.08 percent change
Standard Deviation 17.3
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7
Change at Day 7: CD4
|
6.52 percent change
Standard Deviation 22.6
|
29.39 percent change
Standard Deviation 22.2
|
14.99 percent change
Standard Deviation 56.6
|
24.48 percent change
Standard Deviation 39.3
|
0.91 percent change
Standard Deviation 26.6
|
37.42 percent change
Standard Deviation 33.1
|
-3.28 percent change
Standard Deviation 17.8
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7
Change at Day 7: CD8
|
6.76 percent change
Standard Deviation 18.5
|
31.50 percent change
Standard Deviation 42.3
|
7.21 percent change
Standard Deviation 50.1
|
21.74 percent change
Standard Deviation 37.5
|
1.74 percent change
Standard Deviation 25.2
|
30.95 percent change
Standard Deviation 27.8
|
-3.10 percent change
Standard Deviation 19.8
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7
Change at Day 7: CD16/56
|
-10.57 percent change
Standard Deviation 14.3
|
29.97 percent change
Standard Deviation 56.6
|
17.02 percent change
Standard Deviation 83.0
|
-1.43 percent change
Standard Deviation 40.0
|
-2.37 percent change
Standard Deviation 56.4
|
-7.95 percent change
Standard Deviation 30.2
|
2.26 percent change
Standard Deviation 35.2
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7
Change at Day 7: CD19
|
13.01 percent change
Standard Deviation 36.3
|
34.47 percent change
Standard Deviation 24.6
|
55.54 percent change
Standard Deviation 83.2
|
72.86 percent change
Standard Deviation 67.4
|
15.14 percent change
Standard Deviation 46.0
|
98.64 percent change
Standard Deviation 102.9
|
-2.40 percent change
Standard Deviation 22.3
|
PRIMARY outcome
Timeframe: Baseline, hr 0 on Day 10Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10
Change at Day 10: CD3
|
5.70 percent change
Standard Deviation 18.9
|
8.76 percent change
Standard Deviation 35.7
|
12.47 percent change
Standard Deviation 49.1
|
36.76 percent change
Standard Deviation 43.8
|
11.30 percent change
Standard Deviation 50.0
|
12.61 percent change
Standard Deviation 30.6
|
-3.69 percent change
Standard Deviation 27.9
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10
Change at Day 10: CD4
|
6.86 percent change
Standard Deviation 20.9
|
16.87 percent change
Standard Deviation 34.0
|
14.50 percent change
Standard Deviation 50.8
|
38.22 percent change
Standard Deviation 43.0
|
14.61 percent change
Standard Deviation 54.4
|
16.85 percent change
Standard Deviation 32.4
|
-4.52 percent change
Standard Deviation 27.5
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10
Change at Day 10: CD8
|
5.34 percent change
Standard Deviation 20.9
|
4.13 percent change
Standard Deviation 39.8
|
0.68 percent change
Standard Deviation 35.4
|
28.77 percent change
Standard Deviation 40.5
|
16.81 percent change
Standard Deviation 62.4
|
7.87 percent change
Standard Deviation 20.1
|
-4.14 percent change
Standard Deviation 30.6
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10
Change at Day 10: CD16/56
|
-16.73 percent change
Standard Deviation 29.3
|
-25.53 percent change
Standard Deviation 41.4
|
-16.22 percent change
Standard Deviation 22.8
|
-33.38 percent change
Standard Deviation 27.2
|
-21.99 percent change
Standard Deviation 36.1
|
-37.90 percent change
Standard Deviation 24.8
|
-10.82 percent change
Standard Deviation 31.3
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10
Change at Day 10: CD19
|
24.06 percent change
Standard Deviation 26.9
|
34.97 percent change
Standard Deviation 38.7
|
76.05 percent change
Standard Deviation 71.1
|
79.94 percent change
Standard Deviation 69.2
|
63.64 percent change
Standard Deviation 180.0
|
84.57 percent change
Standard Deviation 109.7
|
-13.19 percent change
Standard Deviation 31.5
|
PRIMARY outcome
Timeframe: Baseline; hr 0, 8 hr post-dose on Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 8 hr post dose on Day 14: CD8
|
10.36 percent change
Standard Deviation 17.3
|
70.26 percent change
Standard Deviation 34.0
|
16.37 percent change
Standard Deviation 16.9
|
40.38 percent change
Standard Deviation 34.4
|
42.59 percent change
Standard Deviation 59.2
|
31.87 percent change
Standard Deviation 86.9
|
-6.94 percent change
Standard Deviation 18.9
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 0 hr post dose on Day 14: CD3
|
1.01 percent change
Standard Deviation 16.0
|
26.93 percent change
Standard Deviation 21.5
|
7.07 percent change
Standard Deviation 33.0
|
14.91 percent change
Standard Deviation 32.1
|
10.74 percent change
Standard Deviation 37.1
|
12.69 percent change
Standard Deviation 43.9
|
-15.05 percent change
Standard Deviation 21.7
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 8 hr post dose on Day 14: CD3
|
7.98 percent change
Standard Deviation 18.2
|
76.59 percent change
Standard Deviation 28.7
|
19.79 percent change
Standard Deviation 23.1
|
40.85 percent change
Standard Deviation 36.7
|
44.08 percent change
Standard Deviation 61.6
|
15.64 percent change
Standard Deviation 32.3
|
-7.20 percent change
Standard Deviation 20.7
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 0 hr post dose on Day 14: CD4
|
-1.91 percent change
Standard Deviation 19.0
|
31.80 percent change
Standard Deviation 11.0
|
9.86 percent change
Standard Deviation 41.2
|
14.80 percent change
Standard Deviation 32.3
|
9.67 percent change
Standard Deviation 49.1
|
17.69 percent change
Standard Deviation 46.8
|
-15.51 percent change
Standard Deviation 25.1
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 8 hr post dose on Day 14: CD4
|
7.31 percent change
Standard Deviation 18.0
|
86.33 percent change
Standard Deviation 30.3
|
22.68 percent change
Standard Deviation 24.8
|
38.65 percent change
Standard Deviation 36.7
|
57.94 percent change
Standard Deviation 91.5
|
19.21 percent change
Standard Deviation 30.4
|
-5.88 percent change
Standard Deviation 23.1
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 0 hr post dose on Day 14: CD8
|
6.92 percent change
Standard Deviation 9.1
|
25.57 percent change
Standard Deviation 37.0
|
-3.36 percent change
Standard Deviation 23.6
|
10.68 percent change
Standard Deviation 30.9
|
17.58 percent change
Standard Deviation 42.4
|
9.89 percent change
Standard Deviation 35.5
|
-14.21 percent change
Standard Deviation 20.2
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 0 hr post dose on Day 14: CD16/56
|
-0.34 percent change
Standard Deviation 25.0
|
1.73 percent change
Standard Deviation 52.8
|
-28.06 percent change
Standard Deviation 32.3
|
-43.06 percent change
Standard Deviation 21.4
|
-20.03 percent change
Standard Deviation 44.6
|
-42.70 percent change
Standard Deviation 35.0
|
-6.49 percent change
Standard Deviation 25.4
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 8 hr post dose on Day 14: CD16/56
|
-8.06 percent change
Standard Deviation 19.7
|
41.85 percent change
Standard Deviation 47.4
|
-6.44 percent change
Standard Deviation 38.0
|
-8.75 percent change
Standard Deviation 46.5
|
45.94 percent change
Standard Deviation 114.4
|
-14.38 percent change
Standard Deviation 37.9
|
-4.09 percent change
Standard Deviation 34.0
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 0 hr post dose on Day 14: CD19
|
16.76 percent change
Standard Deviation 25.1
|
39.97 percent change
Standard Deviation 33.3
|
69.43 percent change
Standard Deviation 75.9
|
68.14 percent change
Standard Deviation 72.2
|
60.99 percent change
Standard Deviation 151.4
|
116.93 percent change
Standard Deviation 215.8
|
-16.04 percent change
Standard Deviation 33.1
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Change at 8 hr post dose on Day 14: CD19
|
20.74 percent change
Standard Deviation 19.8
|
92.47 percent change
Standard Deviation 47.9
|
117.56 percent change
Standard Deviation 52.4
|
95.87 percent change
Standard Deviation 86.6
|
78.60 percent change
Standard Deviation 94.0
|
152.66 percent change
Standard Deviation 263.6
|
2.53 percent change
Standard Deviation 36.2
|
PRIMARY outcome
Timeframe: Baseline, Hour 0 on Day 18Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=4 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18
Change at Day 18: CD4
|
12.44 percent change
Standard Deviation 29.6
|
-13.35 percent change
Standard Deviation 24.9
|
-7.80 percent change
Standard Deviation 21.5
|
-8.89 percent change
Standard Deviation 17.4
|
-13.66 percent change
Standard Deviation 19.1
|
-42.60 percent change
Standard Deviation 18.8
|
7.17 percent change
Standard Deviation 17.1
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18
Change at Day 18: CD19
|
16.98 percent change
Standard Deviation 50.8
|
-15.78 percent change
Standard Deviation 15.9
|
13.95 percent change
Standard Deviation 32.5
|
22.65 percent change
Standard Deviation 45.8
|
-8.14 percent change
Standard Deviation 35.6
|
-29.44 percent change
Standard Deviation 25.4
|
-4.67 percent change
Standard Deviation 25.8
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18
Change at Day 18: CD3
|
13.89 percent change
Standard Deviation 27.9
|
-14.04 percent change
Standard Deviation 30.6
|
-10.24 percent change
Standard Deviation 21.3
|
-10.65 percent change
Standard Deviation 18.5
|
-14.54 percent change
Standard Deviation 13.5
|
-46.69 percent change
Standard Deviation 17.5
|
3.91 percent change
Standard Deviation 20.0
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18
Change at Day 18: CD8
|
17.52 percent change
Standard Deviation 32.7
|
-9.18 percent change
Standard Deviation 44.1
|
-12.38 percent change
Standard Deviation 23.1
|
-18.76 percent change
Standard Deviation 24.0
|
-13.47 percent change
Standard Deviation 8.0
|
-51.68 percent change
Standard Deviation 18.1
|
4.70 percent change
Standard Deviation 15.9
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18
Change at Day 18: CD16/56
|
11.58 percent change
Standard Deviation 31.5
|
-7.64 percent change
Standard Deviation 73.7
|
-21.03 percent change
Standard Deviation 46.0
|
-48.63 percent change
Standard Deviation 63.5
|
-17.13 percent change
Standard Deviation 45.7
|
-76.21 percent change
Standard Deviation 28.2
|
-0.68 percent change
Standard Deviation 22.4
|
PRIMARY outcome
Timeframe: Baseline, hr 0 on Day 21Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21
Change at Day 21: CD3
|
-25.48 percent change
Standard Deviation 10.5
|
-6.38 percent change
Standard Deviation 14.8
|
-42.27 percent change
Standard Deviation 23.9
|
-14.82 percent change
Standard Deviation 20.2
|
-7.93 percent change
Standard Deviation 13.5
|
-27.37 percent change
Standard Deviation 13.3
|
-1.12 percent change
Standard Deviation 17.8
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21
Change at Day 21: CD4
|
-29.75 percent change
Standard Deviation 9.6
|
-2.88 percent change
Standard Deviation 7.4
|
-41.01 percent change
Standard Deviation 24.4
|
-11.01 percent change
Standard Deviation 20.7
|
-9.41 percent change
Standard Deviation 16.5
|
-22.38 percent change
Standard Deviation 13.1
|
1.16 percent change
Standard Deviation 19.8
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21
Change at Day 21: CD8
|
-19.51 percent change
Standard Deviation 14.0
|
-6.00 percent change
Standard Deviation 31.1
|
-43.55 percent change
Standard Deviation 28.9
|
-23.78 percent change
Standard Deviation 21.1
|
-2.12 percent change
Standard Deviation 14.8
|
-32.49 percent change
Standard Deviation 15.6
|
-4.01 percent change
Standard Deviation 17.8
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21
Change at Day 21: CD16/56
|
-7.23 percent change
Standard Deviation 23.5
|
-9.21 percent change
Standard Deviation 63.8
|
-47.87 percent change
Standard Deviation 30.7
|
-48.04 percent change
Standard Deviation 19.0
|
5.62 percent change
Standard Deviation 35.4
|
-66.94 percent change
Standard Deviation 19.2
|
-2.22 percent change
Standard Deviation 44.1
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21
Change at Day 21: CD19
|
-20.90 percent change
Standard Deviation 25.4
|
-14.61 percent change
Standard Deviation 26.7
|
-22.60 percent change
Standard Deviation 26.6
|
-7.67 percent change
Standard Deviation 34.8
|
-17.50 percent change
Standard Deviation 27.7
|
-12.51 percent change
Standard Deviation 22.9
|
0.98 percent change
Standard Deviation 24.3
|
PRIMARY outcome
Timeframe: Baseline, hr 0 on Day 28Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28
Change at Day 28: CD19
|
-7.96 percent change
Standard Deviation 24.3
|
21.29 percent change
Standard Deviation 23.5
|
1.96 percent change
Standard Deviation 42.3
|
-6.53 percent change
Standard Deviation 21.8
|
-16.50 percent change
Standard Deviation 28.3
|
-11.58 percent change
Standard Deviation 22.1
|
-12.51 percent change
Standard Deviation 19.1
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28
Change at Day 28: CD3
|
-18.11 percent change
Standard Deviation 10.0
|
9.29 percent change
Standard Deviation 24.5
|
0.38 percent change
Standard Deviation 34.1
|
-4.60 percent change
Standard Deviation 17.9
|
-7.60 percent change
Standard Deviation 23.3
|
-22.08 percent change
Standard Deviation 9.7
|
-2.57 percent change
Standard Deviation 25.0
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28
Change at Day 28: CD4
|
-21.29 percent change
Standard Deviation 13.3
|
10.97 percent change
Standard Deviation 29.8
|
1.02 percent change
Standard Deviation 35.2
|
-5.90 percent change
Standard Deviation 15.7
|
-11.51 percent change
Standard Deviation 19.8
|
-19.90 percent change
Standard Deviation 6.3
|
-2.86 percent change
Standard Deviation 24.9
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28
Change at Day 28: CD8
|
-11.96 percent change
Standard Deviation 9.0
|
11.58 percent change
Standard Deviation 18.8
|
-2.84 percent change
Standard Deviation 35.0
|
-9.33 percent change
Standard Deviation 18.5
|
-6.13 percent change
Standard Deviation 21.8
|
-23.56 percent change
Standard Deviation 13.7
|
-1.56 percent change
Standard Deviation 26.7
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28
Change at Day 28: CD16/56
|
5.13 percent change
Standard Deviation 35.9
|
21.93 percent change
Standard Deviation 51.3
|
-10.27 percent change
Standard Deviation 31.2
|
-28.52 percent change
Standard Deviation 51.6
|
11.21 percent change
Standard Deviation 55.9
|
-26.96 percent change
Standard Deviation 39.4
|
13.32 percent change
Standard Deviation 50.8
|
PRIMARY outcome
Timeframe: Baseline, hr 0 on Day 42Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42
Change at Day 42: CD19
|
-31.86 percent change
Standard Deviation 30.9
|
6.43 percent change
Standard Deviation 33.6
|
-9.39 percent change
Standard Deviation 29.2
|
-10.22 percent change
Standard Deviation 27.3
|
-20.20 percent change
Standard Deviation 30.0
|
-8.30 percent change
Standard Deviation 16.8
|
-3.93 percent change
Standard Deviation 52.5
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42
Change at Day 42: CD16/56
|
-9.01 percent change
Standard Deviation 25.4
|
21.15 percent change
Standard Deviation 70.8
|
-2.32 percent change
Standard Deviation 27.9
|
2.87 percent change
Standard Deviation 76.1
|
24.08 percent change
Standard Deviation 35.8
|
-4.54 percent change
Standard Deviation 37.4
|
19.90 percent change
Standard Deviation 41.5
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42
Change at Day 42: CD3
|
-20.79 percent change
Standard Deviation 29.0
|
-15.72 percent change
Standard Deviation 29.9
|
-11.58 percent change
Standard Deviation 30.0
|
-1.60 percent change
Standard Deviation 19.5
|
-9.17 percent change
Standard Deviation 21.5
|
-1.63 percent change
Standard Deviation 20.2
|
0.19 percent change
Standard Deviation 32.6
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42
Change at Day 42: CD4
|
-25.65 percent change
Standard Deviation 30.3
|
-19.27 percent change
Standard Deviation 29.2
|
-11.42 percent change
Standard Deviation 30.0
|
-4.08 percent change
Standard Deviation 17.5
|
-12.27 percent change
Standard Deviation 24.6
|
-3.81 percent change
Standard Deviation 12.0
|
0.96 percent change
Standard Deviation 35.7
|
|
Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42
Change at Day 42: CD8
|
-12.74 percent change
Standard Deviation 29.1
|
-10.04 percent change
Standard Deviation 37.2
|
-12.93 percent change
Standard Deviation 33.9
|
-5.60 percent change
Standard Deviation 19.8
|
-3.24 percent change
Standard Deviation 17.6
|
4.19 percent change
Standard Deviation 31.4
|
3.57 percent change
Standard Deviation 33.5
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm group respectively.
The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (\<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, \>= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=2 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=7 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Immune Cell Function at Day 14
Baseline: Stimulated ATP(n=2,5,10,9,9,7,13)
|
222.75 ng/mL
Standard Deviation 157.3
|
205.40 ng/mL
Standard Deviation 143.1
|
429.00 ng/mL
Standard Deviation 115.3
|
406.11 ng/mL
Standard Deviation 171.6
|
210.56 ng/mL
Standard Deviation 104.1
|
252.50 ng/mL
Standard Deviation 146.3
|
301.88 ng/mL
Standard Deviation 152.9
|
|
Change From Baseline in Immune Cell Function at Day 14
Baseline: Unstimulated(Uns) ATP(n=2,5,10,9,9,7,13)
|
11.50 ng/mL
Standard Deviation 9.9
|
10.60 ng/mL
Standard Deviation 3.2
|
16.30 ng/mL
Standard Deviation 6.6
|
16.44 ng/mL
Standard Deviation 10.2
|
14.11 ng/mL
Standard Deviation 8.3
|
7.14 ng/mL
Standard Deviation 5.9
|
16.00 ng/mL
Standard Deviation 12.4
|
|
Change From Baseline in Immune Cell Function at Day 14
Change at Day 14: Stimulated ATP(n=2,5,9,9,9,7,13)
|
92.75 ng/mL
Standard Deviation 120.6
|
95.80 ng/mL
Standard Deviation 135.0
|
155.11 ng/mL
Standard Deviation 168.0
|
90.11 ng/mL
Standard Deviation 125.9
|
118.78 ng/mL
Standard Deviation 88.2
|
61.21 ng/mL
Standard Deviation 124.7
|
26.81 ng/mL
Standard Deviation 66.6
|
|
Change From Baseline in Immune Cell Function at Day 14
Change at Day 14:Uns ATP(n=2,5,9,9,9,7,13)
|
9.50 ng/mL
Standard Deviation 2.8
|
5.60 ng/mL
Standard Deviation 11.4
|
0.44 ng/mL
Standard Deviation 8.9
|
0.33 ng/mL
Standard Deviation 10.6
|
1.67 ng/mL
Standard Deviation 15.4
|
0.29 ng/mL
Standard Deviation 13.1
|
1.46 ng/mL
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 2Population: Analysis population included all participants who met the eligibility criteria. 'n' = participants evaluable for this measure at specified time points for each arm group respectively.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 2
Change at Day 2 (n=5,5,9,9,8,8,12)
|
-6.60 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 21.3
|
-2.00 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 13.7
|
20.00 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 16.1
|
-17.67 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 24.2
|
-10.88 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 19.7
|
-3.75 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 11.1
|
-7.25 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 28.8
|
|
Change From Baseline in Reticulocyte Count at Day 2
Baseline (n=5,5,10,9,9,8,13)
|
124.00 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 30.6
|
94.00 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 36.9
|
81.50 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 20.1
|
95.22 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 14.3
|
80.56 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 24.4
|
79.75 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 25.8
|
100.69 1000 cells/cubic millimeter (cells/mm^3)
Standard Deviation 46.2
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 4Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 4
|
-14.00 1000 cells/mm^3
Standard Deviation 17.2
|
-7.60 1000 cells/mm^3
Standard Deviation 16.5
|
17.33 1000 cells/mm^3
Standard Deviation 26.6
|
-48.44 1000 cells/mm^3
Standard Deviation 13.3
|
-14.67 1000 cells/mm^3
Standard Deviation 16.4
|
-20.00 1000 cells/mm^3
Standard Deviation 14.9
|
-20.85 1000 cells/mm^3
Standard Deviation 41.2
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 7Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 7
|
-3.40 1000 cells/mm^3
Standard Deviation 18.7
|
6.40 1000 cells/mm^3
Standard Deviation 15.9
|
17.11 1000 cells/mm^3
Standard Deviation 26.5
|
-14.44 1000 cells/mm^3
Standard Deviation 13.6
|
3.22 1000 cells/mm^3
Standard Deviation 20.6
|
-30.38 1000 cells/mm^3
Standard Deviation 13.8
|
-1.38 1000 cells/mm^3
Standard Deviation 31.1
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 10Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 10
|
-16.40 1000 cells/mm^3
Standard Deviation 29.5
|
-14.00 1000 cells/mm^3
Standard Deviation 18.3
|
16.00 1000 cells/mm^3
Standard Deviation 25.9
|
-18.22 1000 cells/mm^3
Standard Deviation 15.9
|
6.56 1000 cells/mm^3
Standard Deviation 17.5
|
-29.50 1000 cells/mm^3
Standard Deviation 21.5
|
-3.42 1000 cells/mm^3
Standard Deviation 38.8
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 15Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=7 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 15
|
-24.00 1000 cells/mm^3
Standard Deviation 25.3
|
-11.40 1000 cells/mm^3
Standard Deviation 17.4
|
-8.56 1000 cells/mm^3
Standard Deviation 11.9
|
-42.22 1000 cells/mm^3
Standard Deviation 16.9
|
24.11 1000 cells/mm^3
Standard Deviation 16.8
|
-31.57 1000 cells/mm^3
Standard Deviation 25.9
|
-17.92 1000 cells/mm^3
Standard Deviation 28.4
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 21Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=6 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 21
|
-13.40 1000 cells/mm^3
Standard Deviation 30.6
|
17.60 1000 cells/mm^3
Standard Deviation 11.5
|
44.22 1000 cells/mm^3
Standard Deviation 27.1
|
5.44 1000 cells/mm^3
Standard Deviation 14.4
|
40.25 1000 cells/mm^3
Standard Deviation 15.6
|
-9.17 1000 cells/mm^3
Standard Deviation 23.9
|
12.54 1000 cells/mm^3
Standard Deviation 40.2
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 28Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=8 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 28
|
-16.20 1000 cells/mm^3
Standard Deviation 8.2
|
47.60 1000 cells/mm^3
Standard Deviation 14.8
|
49.56 1000 cells/mm^3
Standard Deviation 24.0
|
23.89 1000 cells/mm^3
Standard Deviation 23.5
|
21.75 1000 cells/mm^3
Standard Deviation 13.6
|
56.00 1000 cells/mm^3
Standard Deviation 24.1
|
-2.85 1000 cells/mm^3
Standard Deviation 32.5
|
PRIMARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1), Day 42Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Day 42
|
-4.60 1000 cells/mm^3
Standard Deviation 12.6
|
-7.00 1000 cells/mm^3
Standard Deviation 35.9
|
34.56 1000 cells/mm^3
Standard Deviation 30.0
|
-3.67 1000 cells/mm^3
Standard Deviation 12.5
|
-2.33 1000 cells/mm^3
Standard Deviation 21.9
|
22.50 1000 cells/mm^3
Standard Deviation 31.7
|
-18.00 1000 cells/mm^3
Standard Deviation 26.7
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42Population: Data was not analyzed as per planned analyses due to pattern of changes observed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=45 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)
|
2696 ng*hr/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1) up to Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Modified Psoriasis Area and Severity Index (mPASI) assessed lesion severity but not the body surface area affected. Severity was estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final mPASI = sum of the each component scores. Total score range 0-12 , higher score indicated more severity.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Erythema: 2
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
9 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Erythema: 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Induration: 1
|
2 participants
|
3 participants
|
5 participants
|
3 participants
|
6 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Scaling: 1
|
3 participants
|
2 participants
|
6 participants
|
7 participants
|
3 participants
|
2 participants
|
8 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Erythema: 0
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Erythema: 1
|
3 participants
|
4 participants
|
8 participants
|
7 participants
|
4 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Erythema: 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Induration: 0
|
0 participants
|
1 participants
|
3 participants
|
4 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Induration: 2
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
9 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Induration: 3
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Induration: 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Scaling: 0
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Scaling: 2
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
4 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Scaling: 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14
Scaling: 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Within 7 days prior to Day 1) up to Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.
Physician global assessment (PGA) of Psoriasis is a 7-point scale used to assess severity of psoriatic plaques, scaling and/or erythema. Severity scale ranged from 1 to 7: 1=severe, 2=moderate to severe, 3=moderate, 4=mild to moderate, 5=mild, 6=almost clear, 7=clear (no sign of psoriasis).
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=9 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 Participants
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 Participants
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
PGA:7
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
PGA:1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
PGA:2
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
PGA:3
|
3 participants
|
1 participants
|
3 participants
|
2 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
PGA:4
|
0 participants
|
3 participants
|
2 participants
|
1 participants
|
4 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
PGA:5
|
1 participants
|
0 participants
|
2 participants
|
4 participants
|
3 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Physician's Global Assessment (PGA) of Psoriasis
PGA:6
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 14Population: Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. 'n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.
Gene expression by quantitative polymerized chain reaction (PCR) using standard curve (SC) method generated by linear regression using log threshold cycle versus log(cell number). Keratin (K)-16, inducible nitric oxide synthase (iNOS), Interleukin 8 (IL-8), CD25, Granzyme B, IL-2, IL-7, IL-15, Interferon-gamma (INF-gamma), C-X-C motif chemokine(CXCL10), perforin 1, B-cell Lymphoma 2 (BCL-2), BCL2 associated X Protein (BAX), Tumor Necrosis Factor Fas Ligand (TNF-FasL), and proliferating cell nuclear antigen (PCNA) presented as control gene normalized expression (relative expression) within SC.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=2 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=2 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=1 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Gene Expression in Psoriatic Plaque Biopsies
IL-2
|
0.98 relative expression unit (REU)
Standard Deviation 0.16
|
0.87 relative expression unit (REU)
Standard Deviation 0.02
|
0.75 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
BCL-2
|
0.47 relative expression unit (REU)
Standard Deviation 0.09
|
0.36 relative expression unit (REU)
Standard Deviation 0.14
|
2.29 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
BAX
|
1.16 relative expression unit (REU)
Standard Deviation 0.21
|
0.83 relative expression unit (REU)
Standard Deviation 0.28
|
0.68 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
CD25
|
7.34 relative expression unit (REU)
Standard Deviation 2.33
|
1.05 relative expression unit (REU)
Standard Deviation 0.27
|
0.16 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
CXCL10
|
15.03 relative expression unit (REU)
Standard Deviation 5.75
|
0.44 relative expression unit (REU)
Standard Deviation 0.45
|
0.04 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
Granzyme B
|
42.71 relative expression unit (REU)
Standard Deviation 18.54
|
1.20 relative expression unit (REU)
Standard Deviation 0.07
|
0.03 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
IL-8
|
556.12 relative expression unit (REU)
Standard Deviation 754.91
|
14.66 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
INOS
|
77.79 relative expression unit (REU)
Standard Deviation 40.10
|
0.97 relative expression unit (REU)
Standard Deviation 0.08
|
0.02 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
INF-gamma
|
2.26 relative expression unit (REU)
Standard Deviation 1.49
|
0.90 relative expression unit (REU)
Standard Deviation 0.09
|
0.22 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
IL-15
|
0.51 relative expression unit (REU)
Standard Deviation 0.01
|
0.70 relative expression unit (REU)
Standard Deviation 0.06
|
0.86 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
IL-7
|
0.85 relative expression unit (REU)
Standard Deviation 0.11
|
1.26 relative expression unit (REU)
Standard Deviation 0.51
|
1.19 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
K-16
|
69.04 relative expression unit (REU)
Standard Deviation 7.60
|
5.18 relative expression unit (REU)
Standard Deviation 2.63
|
0.04 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
PCNA
|
2.09 relative expression unit (REU)
Standard Deviation 0.77
|
1.15 relative expression unit (REU)
Standard Deviation 0.06
|
0.41 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
Perforin
|
2.80 relative expression unit (REU)
Standard Deviation 2.56
|
0.65 relative expression unit (REU)
Standard Deviation 0.17
|
0.23 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Psoriatic Plaque Biopsies
TNF-FasL
|
0.95 relative expression unit (REU)
Standard Deviation 0.24
|
1.24 relative expression unit (REU)
Standard Deviation 0.86
|
0.64 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (within 7 days prior to Day 1), Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm group respectively.
Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against cluster of differentiation 3 (CD3) and cluster of differentiation 8 (CD8) T-lymphocytes, cluster of differentiation 16/56 (CD16/56) natural killer cells, and cluster of differentiation 83 (CD83) mature dendritic cells. Baseline was defined as mean of samples obtained at the screening visit within 7 days prior to Day 1, at the baseline biopsy, and Day 0. Immunohistochemistry results were planned to be analyzed for participants who received CP-690,550 5, 20, 30 mg and matching placebo.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=1 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=1 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=4 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=2 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Baseline: CD83 dermal (n=1,1,4,2)
|
11.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
78.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
18.00 cells/microliter (cells/μL)
Standard Deviation 7.3
|
3.00 cells/microliter (cells/μL)
Standard Deviation 0.0
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Baseline: Absolute CD16/56 (n=0,0,0,0)
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Day 14: CD3 dermal (n=1,1,4,2)
|
120.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
114.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
95.25 cells/microliter (cells/μL)
Standard Deviation 59.4
|
92.00 cells/microliter (cells/μL)
Standard Deviation 53.7
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Baseline: CD3 epidermal (n=1,1,4,2)
|
115.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
108.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
122.50 cells/microliter (cells/μL)
Standard Deviation 50.8
|
124.50 cells/microliter (cells/μL)
Standard Deviation 55.9
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Baseline: CD3 dermal (n=1,1,4,2)
|
189.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
135.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
130.00 cells/microliter (cells/μL)
Standard Deviation 81.3
|
196.00 cells/microliter (cells/μL)
Standard Deviation 99.0
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Baseline: CD8 epidermal (n=1,1,4,2)
|
66.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
55.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
108.50 cells/microliter (cells/μL)
Standard Deviation 40.9
|
71.50 cells/microliter (cells/μL)
Standard Deviation 19.1
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Baseline: CD8 dermal (n=1,1,4,2)
|
23.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
53.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
123.75 cells/microliter (cells/μL)
Standard Deviation 103.6
|
74.00 cells/microliter (cells/μL)
Standard Deviation 70.7
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Baseline: CD83 epidermal (n=1,1,4,2)
|
13.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
44.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
17.00 cells/microliter (cells/μL)
Standard Deviation 12.1
|
1.50 cells/microliter (cells/μL)
Standard Deviation 0.7
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Day 14: CD3 epidermal (n=1,1,4,2)
|
148.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
96.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
82.25 cells/microliter (cells/μL)
Standard Deviation 121.0
|
97.00 cells/microliter (cells/μL)
Standard Deviation 41.0
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Day 14: CD8 epidermal (n=1,1,4,2)
|
85.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
56.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
51.50 cells/microliter (cells/μL)
Standard Deviation 50.8
|
41.50 cells/microliter (cells/μL)
Standard Deviation 34.6
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Day 14: CD8 dermal (n=1,1,4,2)
|
27.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
42.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
90.50 cells/microliter (cells/μL)
Standard Deviation 54.4
|
25.00 cells/microliter (cells/μL)
Standard Deviation 9.9
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Day 14: CD83 epidermal (n=1,1,4,2)
|
42.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.25 cells/microliter (cells/μL)
Standard Deviation 1.5
|
7.00 cells/microliter (cells/μL)
Standard Deviation 9.9
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Day 14: CD83 dermal (n=1,1,4,2)
|
26.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
17.00 cells/microliter (cells/μL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
3.25 cells/microliter (cells/μL)
Standard Deviation 2.2
|
9.50 cells/microliter (cells/μL)
Standard Deviation 9.2
|
—
|
—
|
—
|
|
Immunohistochemistry From Psoriatic Plaque Biopsies
Day 14: Absolute CD16/56 (n=0,0,0,0)
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
NA cells/microliter (cells/μL)
Standard Deviation NA
Data was not analyzed as per planned analyses.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (within 7 days prior to Day 1) up to Day 14Population: Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against K16. Number of participants with K16 expression were assessed qualitatively using suprabasal keratinocytes.
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=1 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=1 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=4 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=2 Participants
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Keratin 16 (K16) Expression
Baseline
|
1 participants
|
1 participants
|
4 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Keratin 16 (K16) Expression
Day 14
|
1 participants
|
1 participants
|
4 participants
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (within 7 days prior to Day 1) up to Day 14Population: Analysis of ICAM-1 in biopsy specimens was not performed as it often continues to be expressed on vessels in the skin even when psoriasis was resolved, thus would not provide a measure of response to therapy.
Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against ICAM-1. Number of participants with ICAM-1 expression was to be assessed qualitatively using epidermal keratinocytes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 14Population: Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. 'n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.
Punch biopsy and serum blood were assayed for messenger Ribonucleic acid (mRNA) gene expression by quantitative PCR using standard curve(SC) method generated by linear regression using log threshold cycle versus log(cell number). granzyme B, IFN-gamma, TNF-alpha (FasL and superfamily member 5 \[SF5\]), BCL2, BAX, iNOS, and CD 25 presented as control gene normalized expression(relative expression) within SC. The Relative mRNA Gene Expression Level is relative to baseline and normalized to the housekeeping gene 18 Svedberg unit ribosomal RNA (18S rRNA).
Outcome measures
| Measure |
CP-690,550 5 mg (Cohort 1)
n=9 Participants
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=9 Participants
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=6 Participants
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Gene Expression in Peripheral Blood
Granzyme B (n=9,9,6)
|
0.69 relative expression unit (REU)
Standard Deviation 0.33
|
0.99 relative expression unit (REU)
Standard Deviation 0.58
|
1.58 relative expression unit (REU)
Standard Deviation 1.13
|
—
|
—
|
—
|
—
|
|
Gene Expression in Peripheral Blood
IFN-gamma (n=9,9,6)
|
2.06 relative expression unit (REU)
Standard Deviation 1.58
|
1.16 relative expression unit (REU)
Standard Deviation 0.59
|
1.46 relative expression unit (REU)
Standard Deviation 0.86
|
—
|
—
|
—
|
—
|
|
Gene Expression in Peripheral Blood
TNF-SF5 (n=9,9,6)
|
1.79 relative expression unit (REU)
Standard Deviation 1.14
|
1.29 relative expression unit (REU)
Standard Deviation 0.48
|
1.24 relative expression unit (REU)
Standard Deviation 0.38
|
—
|
—
|
—
|
—
|
|
Gene Expression in Peripheral Blood
TNF-FasL (n=9,9,6)
|
0.99 relative expression unit (REU)
Standard Deviation 0.37
|
1.09 relative expression unit (REU)
Standard Deviation 0.53
|
1.27 relative expression unit (REU)
Standard Deviation 0.83
|
—
|
—
|
—
|
—
|
|
Gene Expression in Peripheral Blood
BCL2 (n=9,9,6)
|
0.71 relative expression unit (REU)
Standard Deviation 0.40
|
0.90 relative expression unit (REU)
Standard Deviation 0.30
|
1.01 relative expression unit (REU)
Standard Deviation 0.22
|
—
|
—
|
—
|
—
|
|
Gene Expression in Peripheral Blood
BAX (n=9,9,6)
|
1.10 relative expression unit (REU)
Standard Deviation 0.32
|
0.98 relative expression unit (REU)
Standard Deviation 0.25
|
0.97 relative expression unit (REU)
Standard Deviation 0.22
|
—
|
—
|
—
|
—
|
|
Gene Expression in Peripheral Blood
iNOS (n=2,1,1)
|
77.79 relative expression unit (REU)
Standard Deviation 40.10
|
0.97 relative expression unit (REU)
Standard Deviation 0.08
|
0.02 relative expression unit (REU)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
—
|
|
Gene Expression in Peripheral Blood
CD 25 (n=9,9,6)
|
1.19 relative expression unit (REU)
Standard Deviation 0.50
|
1.02 relative expression unit (REU)
Standard Deviation 0.29
|
1.01 relative expression unit (REU)
Standard Deviation 0.24
|
—
|
—
|
—
|
—
|
Adverse Events
CP-690,550 5 mg (Cohort 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CP-690,550 10 mg (Cohort 2)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
CP-690,550 20 mg (Cohort 3)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CP-690,550 30 mg (Cohort 4)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CP-690,550 60 mg (Cohort 5)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CP-690,550 50 mg (Cohort 6)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 participants at risk
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 participants at risk
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 participants at risk
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 participants at risk
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 participants at risk
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 participants at risk
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 participants at risk
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
CP-690,550 5 mg (Cohort 1)
n=5 participants at risk
CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 10 mg (Cohort 2)
n=5 participants at risk
CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 20 mg (Cohort 3)
n=10 participants at risk
CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 30 mg (Cohort 4)
n=9 participants at risk
CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
|
CP-690,550 60 mg (Cohort 5)
n=9 participants at risk
CP-690,550 60 mg tablets orally once daily up to Day 14.
|
CP-690,550 50 mg (Cohort 6)
n=8 participants at risk
CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
|
Placebo
n=13 participants at risk
Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Headache
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Lab test abnormal
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Peripheral edema
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
SGOT increased
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
SGPT increased
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
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