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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Abrocitinib Tablet | Experimental |
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| Part A: Abrocitinib Suspension F1 | Experimental |
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| Part A: Abrocitinib Tablet + Famotidine | Experimental |
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| Part B: Abrocitinib Suspension F1 | Experimental |
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| Part B: Abrocitinib Suspension F2 | Experimental |
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| Part B: Abrocitinib Suspension F3 | Experimental |
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| Part B: Abrocitinib Suspension F4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abrocitinib tablet | Drug | Single dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) or visible rash present during physical examination.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2021 | Jul 13, 2022 |
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Part A: open label / Part B: single-blind
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| Part B: Abrocitinib Suspension F5 | Experimental |
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| Part B: Abrocitinib Suspension F6 | Experimental |
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| Part B: Abrocitinib Suspension F1 + Famotidine | Experimental |
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| Part B: Abrocitinib Suspension F2 + Famotidine | Experimental |
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| Part B: Abrocitinib Suspension F3 + Famotidine | Experimental |
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| Part B: Abrocitinib Suspension F4 + Famotidine | Experimental |
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| Part B: Abrocitinib Suspension F5 + Famotidine | Experimental |
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| Part B: Abrocitinib Suspension F6 + Famotidine | Experimental |
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| Abrocitinib Suspension F1 | Drug | Single dose of abrocitinib 200 mg oral suspension formulation 1 will be administered after an overnight fast of at least 10 hours. |
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| Abrocitinib Suspension F2 | Drug | Single dose of abrocitinib 200 mg oral suspension formulation 2 will be administered after an overnight fast of at least 10 hours. |
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| Abrocitinib Suspension F3 | Drug | Single dose of abrocitinib 200 mg oral suspension formulation 3 will be administered after an overnight fast of at least 10 hours. |
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| Abrocitinib Suspension F4 | Drug | Single dose of abrocitinib 200 mg oral suspension formulation 4 will be administered after an overnight fast of at least 10 hours. |
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| Abrocitinib Suspension F5 | Drug | Single dose of abrocitinib 200 mg oral suspension formulation 5 will be administered after an overnight fast of at least 10 hours. |
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| Abrocitinib Suspension F6 | Drug | Single dose of abrocitinib 200 mg oral suspension formulation 6 will be administered after an overnight fast of at least 10 hours. |
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| Famotidine | Drug | Single dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions. |
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| 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
| 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. | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
| 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. | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
| 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. | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
| 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. | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
| 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. | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
| 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. |
| 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | Baseline up to follow-up (Day 36) |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Participants with laboratory abnormalities (without regard to baseline abnormality) were reported. | Baseline up to follow-up (Day 36) |
| Number of Participants With Clinically Significant Vital Sign Values | Participants with clinically significant vital sign values were reported. | Baseline up to follow-up (Day 36) |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | Participants with clinically significant abnormal ECG values were reported. | Baseline up to follow-up (Day 36) |
| 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. | Baseline up to follow-up (Day 36) |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
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| NOT COMPLETED |
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This was a phase 1, randomized, crossover designed relative bioavailability (rBA) study conducted in healthy adult participants, including 2 parts to investigate the rBA (part A), and taste and palatability (part B) of different formulations. Participants were all healthy adults and were randomized into the study, and may or may not participate both parts of the study. Thus baseline characteristics of participants were combined.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 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. |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 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. |
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| 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. | All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
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| 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. | All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
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| 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. | All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
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| 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. | All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
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| 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. | All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
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| 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. | All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
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| 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. | All participants who had tasted the abrocitinib suspension formulations and made scores on the taste questionnaires were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period. |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
|
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
|
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
|
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
|
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
|
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline up to follow-up (Day 36) |
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| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Participants with laboratory abnormalities (without regard to baseline abnormality) were reported. | 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. | Posted | Count of Participants | Participants | Baseline up to follow-up (Day 36) |
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| Secondary | Number of Participants With Clinically Significant Vital Sign Values | Participants with clinically significant vital sign values were reported. | 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. | Posted | Count of Participants | Participants | Baseline up to follow-up (Day 36) |
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| Secondary | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values | Participants with clinically significant abnormal ECG values were reported. | 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. | Posted | Count of Participants | Participants | Baseline up to follow-up (Day 36) |
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| 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. | All participants who received at least 1 dose of abrocitinib 200 mg alone or abrocitinib 200 mg plus famotidine 40 mg. | Posted | Count of Participants | Participants | Baseline up to follow-up (Day 36) |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abrocitinib 200 mg Commercial Tablet | In part A of the study, abrocitinib 200 mg commercial tablet was administered on Day 1 under fasted conditions. | 0 | 18 | 0 | 18 | 6 | 18 |
| EG001 | Abrocitinib 200 mg Oral Suspension Formulation 1 | In part A of the study, abrocitinib 200 mg oral suspension formulation 1 was administered on Day 1 under fasted conditions. | 0 | 18 | 0 | 18 | 8 | 18 |
| EG002 | Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | In part A of the study, aamotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet were administered on Day 1 under fasted conditions. | 0 | 18 | 0 | 18 | 6 | 18 |
| EG003 | Aborcitinib 200 mg Oral Suspension Formulation 1-6 | 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. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG004 | Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6 | 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. | 0 | 10 | 0 | 10 | 2 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hunger | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2021 | Jul 13, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634427 | abrocitinib |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commecial tablet; Reference: Abrocitinib 200 mg commercial tablet
| Ratio (%) of adjusted geometric means |
| 62.87 |
| 2-Sided |
| 90 |
| 54.85 |
| 72.07 |
| Other |
The ratio and 90% confidence interval were expressed as percentages. |
|
|
|
| OG003 | Abrocitinib 200 mg Oral Suspension Formulation 4 | Participants were given abrocitinib 200 mg oral suspension formulation 4. |
| OG004 | Abrocitinib 200 mg Oral Suspension Formulation 5 | Participants were given abrocitinib 200 mg oral suspension formulation 5. |
| OG005 | Abrocitinib 200 mg Oral Suspension Formulation 6 | Participants were given abrocitinib 200 mg oral suspension formulation 6. |
|
|
| OG003 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 |
Participants were given abrocitinib 200 mg oral suspension formulation 4. |
| OG004 | Abrocitinib 200 mg Oral Suspension Formulation 5 | Participants were given abrocitinib 200 mg oral suspension formulation 5. |
| OG005 | Abrocitinib 200 mg Oral Suspension Formulation 6 | Participants were given abrocitinib 200 mg oral suspension formulation 6. |
|
|
| OG003 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 |
Participants were given abrocitinib 200 mg oral suspension formulation 4. |
| OG004 | Abrocitinib 200 mg Oral Suspension Formulation 5 | Participants were given abrocitinib 200 mg oral suspension formulation 5. |
| OG005 | Abrocitinib 200 mg Oral Suspension Formulation 6 | Participants were given abrocitinib 200 mg oral suspension formulation 6. |
|
|
| OG003 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 |
Participants were given abrocitinib 200 mg oral suspension formulation 4. |
| OG004 | Abrocitinib 200 mg Oral Suspension Formulation 5 | Participants were given abrocitinib 200 mg oral suspension formulation 5. |
| OG005 | Abrocitinib 200 mg Oral Suspension Formulation 6 | Participants were given abrocitinib 200 mg oral suspension formulation 6. |
|
|
| OG003 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 |
Participants were given abrocitinib 200 mg oral suspension formulation 4. |
| OG004 | Abrocitinib 200 mg Oral Suspension Formulation 5 | Participants were given abrocitinib 200 mg oral suspension formulation 5. |
| OG005 | Abrocitinib 200 mg Oral Suspension Formulation 6 | Participants were given abrocitinib 200 mg oral suspension formulation 6. |
|
|
| OG003 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 |
Participants were given abrocitinib 200 mg oral suspension formulation 4. |
| OG004 | Abrocitinib 200 mg Oral Suspension Formulation 5 | Participants were given abrocitinib 200 mg oral suspension formulation 5. |
| OG005 | Abrocitinib 200 mg Oral Suspension Formulation 6 | Participants were given abrocitinib 200 mg oral suspension formulation 6. |
|
|
| OG003 |
| Abrocitinib 200 mg Oral Suspension Formulation 4 |
Participants were given abrocitinib 200 mg oral suspension formulation 4. |
| OG004 | Abrocitinib 200 mg Oral Suspension Formulation 5 | Participants were given abrocitinib 200 mg oral suspension formulation 5. |
| OG005 | Abrocitinib 200 mg Oral Suspension Formulation 6 | Participants were given abrocitinib 200 mg oral suspension formulation 6. |
|
|
|
|
|
|
|
|
| OG002 | Famotidine 40 mg Tablet + Abrocitinib 200 mg Commercial Tablet | In part A of the study, famotidine 40 mg tablet + abrocitinib 200 mg commercial tablet were administered on Day 1 under fasted conditions. |
| OG003 | Abrocitinib 200 mg Oral Suspension Formulation 1-6 | In part B of the study, abrocitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 of each period under fasted conditions. |
| OG004 | Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6 | 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 fasted conditions. |
|
|
| Abrocitinib 200 mg Oral Suspension Formulation 1-6 |
In part B of the study, abrocitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 of each period under fasted conditions. |
| OG004 | Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6 | 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 fasted conditions. |
|
|
In part B of the study, abrocitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 of each period under fasted conditions. |
| OG004 | Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6 | 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 fasted conditions. |
|
|
In part B of the study, abrocitinib 200 mg oral suspension formulation 1-6 were administered on Day 1 of each period under fasted conditions. |
| OG004 | Famotidine 40 mg Tablet + Abrocitinib 200 mg Oral Suspension Formulation 1-6 | 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 fasted conditions. |
|
|
|