Healthy Volunteers
Conditions
Keywords
Abrocitinib, Atopic Dermatitis, Healthy Volunteers, Relative Bioavailability, Taste Assessment
Brief summary
This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.
Detailed description
This is a Phase 1 randomized study in healthy participants to estimate the relative bioavailability of abrocitinib oral suspension (Test formulation) compared to commercial abrocitinib tablet (Reference formulation) under fasted condition. The effect of an acid-reducing agent on the pharmacokinetics of the commercial tablet formulation will be evaluated by administering abrocitinib 200 mg commercial tablet with famotidine 40 mg, as an acid-reducing agent. Assessment of taste and palatability of six different abrocitinib suspension formulations will also be performed. This study consists of 2 parts, as listed below: Part A Part A of the study will be an open label, randomized, single dose, crossover, 3-treatment, 6 sequence, 3-period design in healthy male and/or female adult participants (18-55 years). Healthy participants will be screened within 28 days prior to the first administration of the study intervention to confirm that they meet the participant selection criteria for the study. Eligible participants will be admitted to the CRU on Day -1 and will be confined in the CRU until discharge, on Day 2 of Period 9 in Part B, after completing both Parts A and B of the study. In Part A, participants will be randomized to receive one of the following: a single 200 mg dose of abrocitinib commercial tablet (Treatment A), a single 200 mg dose of abrocitinib oral suspension formulation 1 (Treatment B), or famotidine (40 mg) administered 120 minutes before a single 200 mg dose of abrocitinib commercial tablet (Treatment C). All participants will be fasting for at least 10 hours before taking abrocitinib. Part B Part B will be a single-blind, randomized, 6-period, crossover study in healthy male and/or female adult participants (18-55 years). For any new healthy participants joining Part B only, screening will be performed within 28 days prior to the first administration of the study intervention to confirm that they meet the participant selection criteria for the study. New participants enrolled in Part B only will be admitted to the CRU on Day -1 and will be confined in the CRU until discharge, which is Day 2 of Period 9. On Day 1 of each treatment period under fasted conditions, participants will receive a famotidine tablet (40 mg with 240 mL of room temperature water) administered 120 minutes before a single 200 mg dose of abrocitinib oral suspensions (Formulations 1 to 6) or administered a single 200 mg dose of abrocitinib oral suspension alone (Formulations 1 to 6), after a fast of at least 10 hours before abrocitinib administration.
Interventions
DRUGAbrocitinib tablet
Single dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours.
DRUGAbrocitinib Suspension F1
Single dose of abrocitinib 200 mg oral suspension formulation 1 will be administered after an overnight fast of at least 10 hours.
DRUGAbrocitinib Suspension F2
Single dose of abrocitinib 200 mg oral suspension formulation 2 will be administered after an overnight fast of at least 10 hours.
DRUGAbrocitinib Suspension F3
Single dose of abrocitinib 200 mg oral suspension formulation 3 will be administered after an overnight fast of at least 10 hours.
DRUGAbrocitinib Suspension F4
Single dose of abrocitinib 200 mg oral suspension formulation 4 will be administered after an overnight fast of at least 10 hours.
DRUGAbrocitinib Suspension F5
Single dose of abrocitinib 200 mg oral suspension formulation 5 will be administered after an overnight fast of at least 10 hours.
DRUGAbrocitinib Suspension F6
Single dose of abrocitinib 200 mg oral suspension formulation 6 will be administered after an overnight fast of at least 10 hours.
DRUGFamotidine
Single dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Part A: open label / Part B: single-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination, laboratory tests, and cardiovascular tests. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Capable of giving signed informed consent.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. * Any condition possibly affecting drug absorption (eg, gastrectomy). * History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C virus antibody (HCVAb). * Other acute or chronic medical or psychiatric condition including recent (within the past year). Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) or visible rash present during physical examination. * Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. * A positive urine drug test. * Selected laboratory abnormalities. * History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. * History of tuberculosis (TB) (active or latent). * Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline. * Pregnant female participants; breastfeeding female participants; female participants of childbearing potential who are unwilling or unable to use an acceptable method of contraception. * History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet | 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. | 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. |
| Cmax of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet | 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. | 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. |
| Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. | 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. |
| Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. | 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. |
| Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. | 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. |
| Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. | 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. |
| Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. | 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. |
| Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. | 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. |
| Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | Baseline up to follow-up (Day 36) | Participants with clinically significant abnormal ECG values were reported. |
| 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 | 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. | Area under the plasma concentration time profile from time 0 extrapolated to infinity. |
| Number of Participants With Nausea AEs | Baseline up to follow-up (Day 36) | 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. |
| 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 | 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. | Area under the plasma concentration time profile from time 0 extrapolated to infinity. |
| 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 | 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. | Area under the plasma concentration time profile from time 0 extrapolated to infinity. |
| 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 | 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. | Maximum observed plasma concentration. |
| 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 | 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. | Maximum observed plasma concentration. |
| 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 | 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. | Maximum observed plasma concentration. |
| Number of Participants With Treatment-Emergent Adverse Event | Baseline up to follow-up (Day 36) | 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. |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Baseline up to follow-up (Day 36) | Participants with laboratory abnormalities (without regard to baseline abnormality) were reported. |
| Number of Participants With Clinically Significant Vital Sign Values | Baseline up to follow-up (Day 36) | Participants with clinically significant vital sign values were reported. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 3 |
| 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. | 3 |
| 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. | 4 |
| 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. | 3 |
| 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. | 3 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Treatment A-> B-> C-> D-> E-> F-> G-> H-> I | Treatment A-> C-> B-> L-> M-> N-> B-> J-> K | Treatment B-> A-> C-> K-> L-> M-> N-> B-> J | Treatment B-> C-> A-> I-> D-> E-> F-> G-> H | Treatment C-> A-> B-> H-> I-> D-> E-> F-> G | Treatment C-> B-> A-> J-> K-> L-> M-> N-> B | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.3 Years STANDARD_DEVIATION 18.01 | 34.3 Years STANDARD_DEVIATION 7.51 | 42.3 Years STANDARD_DEVIATION 7.02 | 42.0 Years STANDARD_DEVIATION 6.32 | 34.7 Years STANDARD_DEVIATION 5.86 | 43.3 Years STANDARD_DEVIATION 8.5 | 38.7 Years STANDARD_DEVIATION 9.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 0 Participants | 3 Participants | 4 Participants | 2 Participants | 2 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 6 / 18 | 8 / 18 | 6 / 18 | 5 / 9 | 2 / 10 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 9 | 0 / 10 |
Outcome results
Primary
Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 39.25 Units on a scale | Standard Deviation 30.773 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 36.54 Units on a scale | Standard Deviation 32.008 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 33.80 Units on a scale | Standard Deviation 31.609 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 30.83 Units on a scale | Standard Deviation 31.598 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 47.72 Units on a scale | Standard Deviation 31.067 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 53.30 Units on a scale | Standard Deviation 30.392 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 64.25 Units on a scale | Standard Deviation 27.312 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 39.24 Units on a scale | Standard Deviation 31.325 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 24.92 Units on a scale | Standard Deviation 23.048 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 27.27 Units on a scale | Standard Deviation 25.124 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 31.14 Units on a scale | Standard Deviation 27.875 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 32.06 Units on a scale | Standard Deviation 27.383 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 53.65 Units on a scale | Standard Deviation 25.657 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 45.56 Units on a scale | Standard Deviation 30.635 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 63.62 Units on a scale | Standard Deviation 26.141 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 70.76 Units on a scale | Standard Deviation 27.869 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 57.77 Units on a scale | Standard Deviation 28.066 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 49.41 Units on a scale | Standard Deviation 26.827 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 42.37 Units on a scale | Standard Deviation 27.755 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Bitterness After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 63.28 Units on a scale | Standard Deviation 23.4 |
Primary
Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 40.12 Units on a scale | Standard Deviation 28.336 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 37.26 Units on a scale | Standard Deviation 27.903 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 35.61 Units on a scale | Standard Deviation 29.456 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 34.95 Units on a scale | Standard Deviation 30.347 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 50.57 Units on a scale | Standard Deviation 26.578 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 54.22 Units on a scale | Standard Deviation 26.738 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 61.59 Units on a scale | Standard Deviation 26.218 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 42.22 Units on a scale | Standard Deviation 30.676 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 34.83 Units on a scale | Standard Deviation 33.221 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 35.18 Units on a scale | Standard Deviation 33.222 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 37.81 Units on a scale | Standard Deviation 33.045 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 40.79 Units on a scale | Standard Deviation 33.908 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 55.33 Units on a scale | Standard Deviation 27.451 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 49.27 Units on a scale | Standard Deviation 29.356 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 61.21 Units on a scale | Standard Deviation 25.335 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 63.59 Units on a scale | Standard Deviation 25.544 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 60.48 Units on a scale | Standard Deviation 30.987 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 52.36 Units on a scale | Standard Deviation 31.626 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 44.33 Units on a scale | Standard Deviation 32.906 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Mouth Feel After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 61.59 Units on a scale | Standard Deviation 31.543 |
Primary
Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 0 Hours | 42.32 Units on a scale | Standard Deviation 35.117 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 5 min | 40.21 Units on a scale | Standard Deviation 35.48 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 10 min | 37.78 Units on a scale | Standard Deviation 34.025 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 20 min | 35.55 Units on a scale | Standard Deviation 33.379 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 10 min | 65.65 Units on a scale | Standard Deviation 26.857 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 5 min | 69.59 Units on a scale | Standard Deviation 25.882 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 0 Hours | 72.10 Units on a scale | Standard Deviation 24.243 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 20 min | 64.48 Units on a scale | Standard Deviation 27.644 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 20 min | 37.56 Units on a scale | Standard Deviation 29.758 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 10 min | 38.86 Units on a scale | Standard Deviation 30.808 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 5 min | 42.83 Units on a scale | Standard Deviation 34.549 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 0 Hours | 44.95 Units on a scale | Standard Deviation 34.422 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 10 min | 67.78 Units on a scale | Standard Deviation 24.919 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 20 min | 61.68 Units on a scale | Standard Deviation 28.681 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 5 min | 71.87 Units on a scale | Standard Deviation 24.19 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 0 Hours | 71.08 Units on a scale | Standard Deviation 27.491 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 5 min | 67.34 Units on a scale | Standard Deviation 27.632 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 10 min | 62.89 Units on a scale | Standard Deviation 30.153 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 20 min | 57.95 Units on a scale | Standard Deviation 28.483 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Overall Liking After Administering Each Abrocitinib Oral Suspension Formulation (Formulation [F]1-F6) in Part B | 0 Hours | 69.29 Units on a scale | Standard Deviation 27.565 |
Primary
Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 19.73 Units on a scale | Standard Deviation 26.872 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 19.34 Units on a scale | Standard Deviation 27.435 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 19.43 Units on a scale | Standard Deviation 27.776 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 19.61 Units on a scale | Standard Deviation 27.872 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 29.49 Units on a scale | Standard Deviation 26.602 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 35.56 Units on a scale | Standard Deviation 28.372 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 39.52 Units on a scale | Standard Deviation 31.19 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 25.62 Units on a scale | Standard Deviation 26.613 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 12.35 Units on a scale | Standard Deviation 17.234 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 12.29 Units on a scale | Standard Deviation 17.121 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 13.78 Units on a scale | Standard Deviation 17.276 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 19.84 Units on a scale | Standard Deviation 21.56 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 21.29 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 25.33 Units on a scale | Standard Deviation 22.853 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 20.89 Units on a scale | Standard Deviation 19.444 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 33.43 Units on a scale | Standard Deviation 24.688 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 39.24 Units on a scale | Standard Deviation 30.962 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 30.92 Units on a scale | Standard Deviation 30.413 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 31.85 Units on a scale | Standard Deviation 33.229 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 28.60 Units on a scale | Standard Deviation 28.337 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Salty Taste After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 34.98 Units on a scale | Standard Deviation 31.103 |
Primary
Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 25.44 Units on a scale | Standard Deviation 26.343 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 24.54 Units on a scale | Standard Deviation 26.919 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 23.16 Units on a scale | Standard Deviation 27.074 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 21.68 Units on a scale | Standard Deviation 27.373 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 42.44 Units on a scale | Standard Deviation 29.892 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 46.32 Units on a scale | Standard Deviation 28.172 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 52.54 Units on a scale | Standard Deviation 27.703 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 37.05 Units on a scale | Standard Deviation 30.426 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 16.95 Units on a scale | Standard Deviation 21.472 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 18.70 Units on a scale | Standard Deviation 21.879 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 21.75 Units on a scale | Standard Deviation 23.849 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 24.86 Units on a scale | Standard Deviation 24.663 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 33.30 Units on a scale | Standard Deviation 31.797 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 28.98 Units on a scale | Standard Deviation 31.338 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 41.02 Units on a scale | Standard Deviation 31.652 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 48.35 Units on a scale | Standard Deviation 34.21 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 39.73 Units on a scale | Standard Deviation 32.655 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 36.33 Units on a scale | Standard Deviation 32.522 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 34.31 Units on a scale | Standard Deviation 31.151 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sour Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 47.37 Units on a scale | Standard Deviation 33.103 |
Primary
Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 31.16 Units on a scale | Standard Deviation 26.157 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 38.02 Units on a scale | Standard Deviation 30.485 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 40.42 Units on a scale | Standard Deviation 32.265 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 44.54 Units on a scale | Standard Deviation 34.296 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 78.35 Units on a scale | Standard Deviation 23.383 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 78.32 Units on a scale | Standard Deviation 23.269 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 82.16 Units on a scale | Standard Deviation 19.816 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 75.18 Units on a scale | Standard Deviation 26.743 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 35.46 Units on a scale | Standard Deviation 29.622 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 33.52 Units on a scale | Standard Deviation 29.713 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 33.14 Units on a scale | Standard Deviation 28.948 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 30.16 Units on a scale | Standard Deviation 29.536 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 74.86 Units on a scale | Standard Deviation 29.812 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 73.46 Units on a scale | Standard Deviation 31.151 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 76.60 Units on a scale | Standard Deviation 28.824 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 78.48 Units on a scale | Standard Deviation 28.017 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 72.84 Units on a scale | Standard Deviation 29.862 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 64.81 Units on a scale | Standard Deviation 33.275 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 62.50 Units on a scale | Standard Deviation 33.72 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Sweet Taste After Administering Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 74.53 Units on a scale | Standard Deviation 29.874 |
Primary
Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 28.90 Units on a scale | Standard Deviation 26.489 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 24.48 Units on a scale | Standard Deviation 25.226 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 23.73 Units on a scale | Standard Deviation 26.631 |
| Abrocitinib 200 mg Commercial Tablet | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 21.65 Units on a scale | Standard Deviation 28.937 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 31.24 Units on a scale | Standard Deviation 26.305 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 35.40 Units on a scale | Standard Deviation 28.451 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 41.87 Units on a scale | Standard Deviation 30.238 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 23.97 Units on a scale | Standard Deviation 26.386 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 15.40 Units on a scale | Standard Deviation 20.156 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | 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 20.001 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 22.86 Units on a scale | Standard Deviation 22.477 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 25.87 Units on a scale | Standard Deviation 23.92 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 22.82 Units on a scale | Standard Deviation 25.042 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 17.68 Units on a scale | Standard Deviation 21.927 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 28.76 Units on a scale | Standard Deviation 25.809 |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 35.75 Units on a scale | Standard Deviation 30.848 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 5 min | 37.89 Units on a scale | Standard Deviation 33.134 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 10 min | 36.99 Units on a scale | Standard Deviation 32.737 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 20 min | 33.68 Units on a scale | Standard Deviation 32.903 |
| Abrocitinib 200 mg Oral Suspension Formulation 6 | Assessment of Tongue/Mouth Burn After Administering Each Abrocitinib Oral Suspension Formulation (F1-F6) in Part B | 0 Hours | 41.05 Units on a scale | Standard Deviation 32.462 |
Primary
AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet | 4601 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 54 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet | 3096 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 61 |
Comparison: Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet90% CI: [85.43, 110.03]
Comparison: Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commecial tablet; Reference: Abrocitinib 200 mg commercial tablet90% CI: [54.85, 72.07]
Primary
Cmax of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Cmax of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet | 1218 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 56 |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Cmax of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet | 189.1 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 77 |
Comparison: Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet90% CI: [80.28, 124.74]
Comparison: Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet; Reference: Abrocitinib 200 mg commercial tablet90% CI: [12.46, 19.36]
Secondary
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
Area under the plasma concentration time profile from time 0 extrapolated to infinity.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | 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 | 903.2 ng*hr/mL | Geometric Coefficient of Variation 32 |
Secondary
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
Area under the plasma concentration time profile from time 0 extrapolated to infinity.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | 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 | 1705 ng*hr/mL | Geometric Coefficient of Variation 33 |
Secondary
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
Area under the plasma concentration time profile from time 0 extrapolated to infinity.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | 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 | 1108 ng*hr/mL | Geometric Coefficient of Variation 15 |
Secondary
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
Maximum observed plasma concentration.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | 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 | 57.38 ng/mL | Geometric Coefficient of Variation 55 |
Secondary
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
Maximum observed plasma concentration.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | 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 | 87.96 ng/mL | Geometric Coefficient of Variation 47 |
Secondary
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
Maximum observed plasma concentration.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | 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 |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | 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 | 56.42 ng/mL | Geometric Coefficient of Variation 42 |
Secondary
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values
Participants with clinically significant abnormal ECG values were reported.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | 0 Participants |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Sign Values
Participants with clinically significant vital sign values were reported.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Number of Participants With Clinically Significant Vital Sign Values | 0 Participants |
Secondary
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Participants with laboratory abnormalities (without regard to baseline abnormality) were reported.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 0 Participants |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 0 Participants |
Secondary
Number of Participants With Nausea AEs
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Number of Participants With Nausea AEs | 12 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Number of Participants With Nausea AEs | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Event
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abrocitinib 200 mg Commercial Tablet | Number of Participants With Treatment-Emergent Adverse Event | SAEs | 0 Participants |
| Abrocitinib 200 mg Commercial Tablet | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related AEs | 3 Participants |
| Abrocitinib 200 mg Commercial Tablet | Number of Participants With Treatment-Emergent Adverse Event | All-causality AEs | 6 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related AEs | 5 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Number of Participants With Treatment-Emergent Adverse Event | All-causality AEs | 8 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 1 | Number of Participants With Treatment-Emergent Adverse Event | SAEs | 0 Participants |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related AEs | 0 Participants |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Number of Participants With Treatment-Emergent Adverse Event | SAEs | 0 Participants |
| Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | Number of Participants With Treatment-Emergent Adverse Event | All-causality AEs | 6 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | Number of Participants With Treatment-Emergent Adverse Event | All-causality AEs | 5 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related AEs | 4 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 4 | Number of Participants With Treatment-Emergent Adverse Event | SAEs | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Number of Participants With Treatment-Emergent Adverse Event | SAEs | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Number of Participants With Treatment-Emergent Adverse Event | Treatment-related AEs | 0 Participants |
| Abrocitinib 200 mg Oral Suspension Formulation 5 | Number of Participants With Treatment-Emergent Adverse Event | All-causality AEs | 2 Participants |