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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 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.

Results posted on

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Abrocitinib 200 mg Oral Suspension Formulation 1

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Aborcitinib 200 mg Oral Suspension Formulation 1-6

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place