Trial Outcomes & Findings for A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations. (NCT NCT04903093)
NCT ID: NCT04903093
Last Updated: 2024-11-14
Results Overview
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
COMPLETED
PHASE1
19 participants
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.
2024-11-14
Participant Flow
Part A was a crossover, 3-treatment, 6-sequence, 3-periods design. With completion of Part A of the study, participants entered Part B, which included 6 periods with 6 sequences. Thus, participants who completed Part A and then Part B were combined. Enrolled participants, including 18 participants who completed both Parts A and B and 1 participant who withdrew by the participant, are presented in the Participant Flow.
Participant milestones
| Measure |
Treatment A-> B-> C-> D-> E-> F-> G-> H-> I
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment A-> C-> B-> L-> M-> N-> B-> J-> K
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment B-> A-> C-> K-> L-> M-> N-> B-> J
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment B-> C-> A-> I-> D-> E-> F-> G-> H
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment C-> A-> B-> H-> I-> D-> E-> F-> G
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment C-> B-> A-> J-> K-> L-> M-> N-> B
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment A-> B-> C-> D-> E-> F-> G-> H-> I
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment A-> C-> B-> L-> M-> N-> B-> J-> K
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment B-> A-> C-> K-> L-> M-> N-> B-> J
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment B-> C-> A-> I-> D-> E-> F-> G-> H
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment C-> A-> B-> H-> I-> D-> E-> F-> G
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment C-> B-> A-> J-> K-> L-> M-> N-> B
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.
Baseline characteristics by cohort
| Measure |
Treatment A-> B-> C-> D-> E-> F-> G-> H-> I
n=3 Participants
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment A-> C-> B-> L-> M-> N-> B-> J-> K
n=3 Participants
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment B-> A-> C-> K-> L-> M-> N-> B-> J
n=3 Participants
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment B-> C-> A-> I-> D-> E-> F-> G-> H
n=4 Participants
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment C-> A-> B-> H-> I-> D-> E-> F-> G
n=3 Participants
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Treatment C-> B-> A-> J-> K-> L-> M-> N-> B
n=3 Participants
Part A of the study included administration of treatments A - C. A=a single dose of abrocitinib 200 mg commercial tablet; B=a single dose of abrocitinib 200 mg oral suspension formulation 1, C=famotidine (40 mg) administered 120 minutes before a single dose of 200 mg abrocitinib commercial tablet.
Part B of the study included administration of treatments D - I, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation X (X=1-6), and treatments B, J - N, abrocitinib 200 mg oral suspension formulation X (X=1-6) only.
All were under fasted state on Day 1 of each period.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 18.01 • n=5 Participants
|
34.3 Years
STANDARD_DEVIATION 7.51 • n=7 Participants
|
42.3 Years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
42.0 Years
STANDARD_DEVIATION 6.32 • n=4 Participants
|
34.7 Years
STANDARD_DEVIATION 5.86 • n=21 Participants
|
43.3 Years
STANDARD_DEVIATION 8.50 • n=10 Participants
|
38.7 Years
STANDARD_DEVIATION 9.14 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet
|
—
|
—
|
—
|
4623 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 66
|
4601 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
3096 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 61
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Maximum observed plasma concentration (Cmax) was measured. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Cmax of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet
|
—
|
—
|
—
|
1264 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 67
|
1218 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
189.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 77
|
PRIMARY outcome
Timeframe: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.Population: All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B
5 min
|
40.32 Units on a scale
Standard Deviation 32.691
|
71.87 Units on a scale
Standard Deviation 24.190
|
67.34 Units on a scale
Standard Deviation 27.632
|
40.21 Units on a scale
Standard Deviation 35.480
|
69.59 Units on a scale
Standard Deviation 25.882
|
42.83 Units on a scale
Standard Deviation 34.549
|
|
Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B
20 min
|
31.97 Units on a scale
Standard Deviation 29.563
|
61.68 Units on a scale
Standard Deviation 28.681
|
57.95 Units on a scale
Standard Deviation 28.483
|
35.55 Units on a scale
Standard Deviation 33.379
|
64.48 Units on a scale
Standard Deviation 27.644
|
37.56 Units on a scale
Standard Deviation 29.758
|
|
Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B
0 Hours
|
42.19 Units on a scale
Standard Deviation 34.366
|
71.08 Units on a scale
Standard Deviation 27.491
|
69.29 Units on a scale
Standard Deviation 27.565
|
42.32 Units on a scale
Standard Deviation 35.117
|
72.10 Units on a scale
Standard Deviation 24.243
|
44.95 Units on a scale
Standard Deviation 34.422
|
|
Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B
10 min
|
33.90 Units on a scale
Standard Deviation 29.544
|
67.78 Units on a scale
Standard Deviation 24.919
|
62.89 Units on a scale
Standard Deviation 30.153
|
37.78 Units on a scale
Standard Deviation 34.025
|
65.65 Units on a scale
Standard Deviation 26.857
|
38.86 Units on a scale
Standard Deviation 30.808
|
PRIMARY outcome
Timeframe: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.Population: All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
5 min
|
38.67 Units on a scale
Standard Deviation 27.688
|
61.21 Units on a scale
Standard Deviation 25.335
|
60.48 Units on a scale
Standard Deviation 30.987
|
37.26 Units on a scale
Standard Deviation 27.903
|
54.22 Units on a scale
Standard Deviation 26.738
|
37.81 Units on a scale
Standard Deviation 33.045
|
|
Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
10 min
|
31.90 Units on a scale
Standard Deviation 24.808
|
55.33 Units on a scale
Standard Deviation 27.451
|
52.36 Units on a scale
Standard Deviation 31.626
|
35.61 Units on a scale
Standard Deviation 29.456
|
50.57 Units on a scale
Standard Deviation 26.578
|
35.18 Units on a scale
Standard Deviation 33.222
|
|
Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
20 min
|
26.89 Units on a scale
Standard Deviation 23.277
|
49.27 Units on a scale
Standard Deviation 29.356
|
44.33 Units on a scale
Standard Deviation 32.906
|
34.95 Units on a scale
Standard Deviation 30.347
|
42.22 Units on a scale
Standard Deviation 30.676
|
34.83 Units on a scale
Standard Deviation 33.221
|
|
Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
0 Hours
|
42.10 Units on a scale
Standard Deviation 30.178
|
63.59 Units on a scale
Standard Deviation 25.544
|
61.59 Units on a scale
Standard Deviation 31.543
|
40.12 Units on a scale
Standard Deviation 28.336
|
61.59 Units on a scale
Standard Deviation 26.218
|
40.79 Units on a scale
Standard Deviation 33.908
|
PRIMARY outcome
Timeframe: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.Population: All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
0 Hours
|
28.63 Units on a scale
Standard Deviation 21.634
|
70.76 Units on a scale
Standard Deviation 27.869
|
63.28 Units on a scale
Standard Deviation 23.400
|
39.25 Units on a scale
Standard Deviation 30.773
|
64.25 Units on a scale
Standard Deviation 27.312
|
32.06 Units on a scale
Standard Deviation 27.383
|
|
Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
5 min
|
25.21 Units on a scale
Standard Deviation 19.685
|
63.62 Units on a scale
Standard Deviation 26.141
|
57.77 Units on a scale
Standard Deviation 28.066
|
36.54 Units on a scale
Standard Deviation 32.008
|
53.30 Units on a scale
Standard Deviation 30.392
|
31.14 Units on a scale
Standard Deviation 27.875
|
|
Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
10 min
|
20.95 Units on a scale
Standard Deviation 19.000
|
53.65 Units on a scale
Standard Deviation 25.657
|
49.41 Units on a scale
Standard Deviation 26.827
|
33.80 Units on a scale
Standard Deviation 31.609
|
47.72 Units on a scale
Standard Deviation 31.067
|
27.27 Units on a scale
Standard Deviation 25.124
|
|
Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
20 min
|
18.19 Units on a scale
Standard Deviation 19.554
|
45.56 Units on a scale
Standard Deviation 30.635
|
42.37 Units on a scale
Standard Deviation 27.755
|
30.83 Units on a scale
Standard Deviation 31.598
|
39.24 Units on a scale
Standard Deviation 31.325
|
24.92 Units on a scale
Standard Deviation 23.048
|
PRIMARY outcome
Timeframe: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.Population: All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
0 Hours
|
26.89 Units on a scale
Standard Deviation 25.884
|
35.75 Units on a scale
Standard Deviation 30.848
|
41.05 Units on a scale
Standard Deviation 32.462
|
28.90 Units on a scale
Standard Deviation 26.489
|
41.87 Units on a scale
Standard Deviation 30.238
|
25.87 Units on a scale
Standard Deviation 23.920
|
|
Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
5 min
|
22.67 Units on a scale
Standard Deviation 24.999
|
28.76 Units on a scale
Standard Deviation 25.809
|
37.89 Units on a scale
Standard Deviation 33.134
|
24.48 Units on a scale
Standard Deviation 25.226
|
35.40 Units on a scale
Standard Deviation 28.451
|
22.86 Units on a scale
Standard Deviation 22.477
|
|
Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
10 min
|
18.29 Units on a scale
Standard Deviation 22.999
|
22.82 Units on a scale
Standard Deviation 25.042
|
36.99 Units on a scale
Standard Deviation 32.737
|
23.73 Units on a scale
Standard Deviation 26.631
|
31.24 Units on a scale
Standard Deviation 26.305
|
18.29 Units on a scale
Standard Deviation 20.001
|
|
Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
20 min
|
16.51 Units on a scale
Standard Deviation 22.374
|
17.68 Units on a scale
Standard Deviation 21.927
|
33.68 Units on a scale
Standard Deviation 32.903
|
21.65 Units on a scale
Standard Deviation 28.937
|
23.97 Units on a scale
Standard Deviation 26.386
|
15.40 Units on a scale
Standard Deviation 20.156
|
PRIMARY outcome
Timeframe: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.Population: All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
0 Hours
|
21.84 Units on a scale
Standard Deviation 21.319
|
39.24 Units on a scale
Standard Deviation 30.962
|
34.98 Units on a scale
Standard Deviation 31.103
|
19.73 Units on a scale
Standard Deviation 26.872
|
39.52 Units on a scale
Standard Deviation 31.190
|
19.84 Units on a scale
Standard Deviation 21.560
|
|
Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
5 min
|
19.49 Units on a scale
Standard Deviation 22.504
|
33.43 Units on a scale
Standard Deviation 24.688
|
30.92 Units on a scale
Standard Deviation 30.413
|
19.34 Units on a scale
Standard Deviation 27.435
|
35.56 Units on a scale
Standard Deviation 28.372
|
13.78 Units on a scale
Standard Deviation 17.276
|
|
Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
10 min
|
15.94 Units on a scale
Standard Deviation 21.414
|
25.33 Units on a scale
Standard Deviation 22.853
|
31.85 Units on a scale
Standard Deviation 33.229
|
19.43 Units on a scale
Standard Deviation 27.776
|
29.49 Units on a scale
Standard Deviation 26.602
|
12.29 Units on a scale
Standard Deviation 17.121
|
|
Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
20 min
|
15.68 Units on a scale
Standard Deviation 21.290
|
20.89 Units on a scale
Standard Deviation 19.444
|
28.60 Units on a scale
Standard Deviation 28.337
|
19.61 Units on a scale
Standard Deviation 27.872
|
25.62 Units on a scale
Standard Deviation 26.613
|
12.35 Units on a scale
Standard Deviation 17.234
|
PRIMARY outcome
Timeframe: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.Population: All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
0 Hours
|
25.65 Units on a scale
Standard Deviation 22.452
|
48.35 Units on a scale
Standard Deviation 34.210
|
47.37 Units on a scale
Standard Deviation 33.103
|
25.44 Units on a scale
Standard Deviation 26.343
|
52.54 Units on a scale
Standard Deviation 27.703
|
24.86 Units on a scale
Standard Deviation 24.663
|
|
Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
5 min
|
21.71 Units on a scale
Standard Deviation 22.198
|
41.02 Units on a scale
Standard Deviation 31.652
|
39.73 Units on a scale
Standard Deviation 32.655
|
24.54 Units on a scale
Standard Deviation 26.919
|
46.32 Units on a scale
Standard Deviation 28.172
|
21.75 Units on a scale
Standard Deviation 23.849
|
|
Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
20 min
|
18.16 Units on a scale
Standard Deviation 20.241
|
28.98 Units on a scale
Standard Deviation 31.338
|
34.31 Units on a scale
Standard Deviation 31.151
|
21.68 Units on a scale
Standard Deviation 27.373
|
37.05 Units on a scale
Standard Deviation 30.426
|
16.95 Units on a scale
Standard Deviation 21.472
|
|
Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
10 min
|
19.18 Units on a scale
Standard Deviation 20.652
|
33.30 Units on a scale
Standard Deviation 31.797
|
36.33 Units on a scale
Standard Deviation 32.522
|
23.16 Units on a scale
Standard Deviation 27.074
|
42.44 Units on a scale
Standard Deviation 29.892
|
18.70 Units on a scale
Standard Deviation 21.879
|
PRIMARY outcome
Timeframe: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.Population: All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis.
For the taste assessment in Part B of the study, the data used in the analysis was transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=19 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
0 Hours
|
27.90 Units on a scale
Standard Deviation 24.626
|
78.48 Units on a scale
Standard Deviation 28.017
|
74.53 Units on a scale
Standard Deviation 29.874
|
31.16 Units on a scale
Standard Deviation 26.157
|
82.16 Units on a scale
Standard Deviation 19.816
|
30.16 Units on a scale
Standard Deviation 29.536
|
|
Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
5 min
|
31.56 Units on a scale
Standard Deviation 29.205
|
76.60 Units on a scale
Standard Deviation 28.824
|
72.84 Units on a scale
Standard Deviation 29.862
|
38.02 Units on a scale
Standard Deviation 30.485
|
78.32 Units on a scale
Standard Deviation 23.269
|
33.14 Units on a scale
Standard Deviation 28.948
|
|
Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
20 min
|
33.33 Units on a scale
Standard Deviation 31.472
|
73.46 Units on a scale
Standard Deviation 31.151
|
62.50 Units on a scale
Standard Deviation 33.720
|
44.54 Units on a scale
Standard Deviation 34.296
|
75.18 Units on a scale
Standard Deviation 26.743
|
35.46 Units on a scale
Standard Deviation 29.622
|
|
Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
10 min
|
32.38 Units on a scale
Standard Deviation 32.348
|
74.86 Units on a scale
Standard Deviation 29.812
|
64.81 Units on a scale
Standard Deviation 33.275
|
40.42 Units on a scale
Standard Deviation 32.265
|
78.35 Units on a scale
Standard Deviation 23.383
|
33.52 Units on a scale
Standard Deviation 29.713
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Area under the plasma concentration time profile from time 0 extrapolated to infinity.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=13 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
AUCinf of Abrocitinib Metabolite (PF-06471658/M1) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A
|
—
|
—
|
—
|
1048 ng*hr/mL
Geometric Coefficient of Variation 34
|
903.2 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Area under the plasma concentration time profile from time 0 extrapolated to infinity.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=17 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=7 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
AUCinf of Abrocitinib Metabolite (PF-07055087/M2) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A
|
—
|
—
|
—
|
1369 ng*hr/mL
Geometric Coefficient of Variation 22
|
1108 ng*hr/mL
Geometric Coefficient of Variation 15
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Area under the plasma concentration time profile from time 0 extrapolated to infinity.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=15 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=13 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
AUCinf of Abrocitinib Metabolite (PF-07054874/M4) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A
|
—
|
—
|
—
|
2139 ng*hr/mL
Geometric Coefficient of Variation 34
|
1705 ng*hr/mL
Geometric Coefficient of Variation 33
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Maximum observed plasma concentration.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Cmax of Abrocitinib Metabolite (PF-06471658/M1) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A
|
—
|
—
|
—
|
216.8 ng/mL
Geometric Coefficient of Variation 82
|
57.38 ng/mL
Geometric Coefficient of Variation 55
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Maximum observed plasma concentration.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Cmax of Abrocitinib Metabolite (PF-07055087/M2) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A
|
—
|
—
|
—
|
214.3 ng/mL
Geometric Coefficient of Variation 58
|
56.42 ng/mL
Geometric Coefficient of Variation 42
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose on Day 1 of each period.Population: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
Maximum observed plasma concentration.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=17 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Cmax of Abrocitinib Metabolite (PF-07054874/M4) Following the Administration of Abrocitinib 1×200 mg Tablet With or Without Famotidine 40 mg in Part A
|
—
|
—
|
—
|
400.5 ng/mL
Geometric Coefficient of Variation 39
|
87.96 ng/mL
Geometric Coefficient of Variation 47
|
—
|
SECONDARY outcome
Timeframe: Baseline up to follow-up (Day 36)Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product, without regard to relatedness. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study intervention was determined by the investigator.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=9 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=10 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Event
All-causality AEs
|
5 Participants
|
2 Participants
|
—
|
6 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Event
Treatment-related AEs
|
4 Participants
|
0 Participants
|
—
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Event
SAEs
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to follow-up (Day 36)Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Participants with laboratory abnormalities (without regard to baseline abnormality) were reported.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=9 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=10 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to follow-up (Day 36)Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Participants with clinically significant vital sign values were reported.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=9 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=10 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Values
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to follow-up (Day 36)Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Participants with clinically significant abnormal ECG values were reported.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
n=9 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
n=10 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
n=18 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to follow-up (Day 36)Population: All participants who received at least 1 dose of abrocitinib 200 mg alone or abrocitinib 200 mg plus famotidine 40 mg.
Number of participants who received abrocitinib 200 mg alone and who received abrocitinib 200 mg plus famotidine 40 mg and had nausea AEs were reported.
Outcome measures
| Measure |
Abrocitinib 200 mg Oral Suspension Formulation 4
Participants were given abrocitinib 200 mg oral suspension formulation 4.
|
Abrocitinib 200 mg Oral Suspension Formulation 5
Participants were given abrocitinib 200 mg oral suspension formulation 5.
|
Abrocitinib 200 mg Oral Suspension Formulation 6
Participants were given abrocitinib 200 mg oral suspension formulation 6.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=45 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 1.
|
Abrocitinib 200 mg Oral Suspension Formulation 2
n=28 Participants
Participants were given abrocitinib 200 mg oral suspension formulation 2.
|
Abrocitinib 200 mg Oral Suspension Formulation 3
Participants were given abrocitinib 200 mg oral suspension formulation 3.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Nausea AEs
|
—
|
—
|
—
|
12 Participants
|
0 Participants
|
—
|
Adverse Events
Abrocitinib 200 mg Commercial Tablet
Abrocitinib 200 mg Oral Suspension Formulation 1
Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet
Aborcitinib 200 mg Oral Suspension Formulation 1-6
Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abrocitinib 200 mg Commercial Tablet
n=18 participants at risk
In part A of the study, abrocitinib 200 mg commercial tablet was administered on Day 1 under fasted conditions.
|
Abrocitinib 200 mg Oral Suspension Formulation 1
n=18 participants at risk
In part A of the study, abrocitinib 200 mg oral suspension formulation 1 was administered on Day 1 under fasted conditions.
|
Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet
n=18 participants at risk
In part A of the study, aamotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet were administered on Day 1 under fasted conditions.
|
Aborcitinib 200 mg Oral Suspension Formulation 1-6
n=9 participants at risk
In part B of the study, aborcitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 od each period under fasting conditions.
|
Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6
n=10 participants at risk
In part B of the study, famotidine 40 mg tablet + abrocitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 of each period under fasting conditions.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
27.8%
5/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
44.4%
4/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
General disorders
Feeling abnormal
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
11.1%
1/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
General disorders
Hunger
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
22.2%
2/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
11.1%
1/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
11.1%
2/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
11.1%
2/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
22.2%
4/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
16.7%
3/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
11.1%
1/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
10.0%
1/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
10.0%
1/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
10.0%
1/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/18 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
11.1%
1/9 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
0.00%
0/10 • Baseline up to follow-up (Day 36)
Occurrences of AEs in this study were reported according to the study interventions that participants received, according to the study safety objective. Abrocitinib 200 mg oral suspension formulations (with different flavors) were prepared with different levels of flavor and sweetener at study site, and any AEs occurrences for these study interventions were combined to ensure the presentation of safety profiles of Abrocitinib 200 mg oral suspension formulation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place