Healthy VolunteersPhase 1NCT04903093
A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations.
A Phase 1 study testing Abrocitinib tablet, Abrocitinib Suspension F1 and Abrocitinib Suspension F2 in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Abrocitinib tablet, Abrocitinib Suspension F1 and Abrocitinib Suspension F2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2021to 26 Oct 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, RANDOMIZED, CROSSOVER STUDY TO EVALUATE RELATIVE BIOAVAILABILITY OF ABROCITINIB ORAL SUSPENSION AND EFFECT OF AN ACID-REDUCING AGENT ON THE BIOAVAILABILITY OF ABROCITINIB COMMERCIAL TABLET AND TO ASSESS THE TASTE OF ABROCITINIB ORAL FORMULATIONS IN HEALTHY ADULT PARTICIPANTS AGED 18 TO 55 YEARS OF AGE.
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Abrocitinib tablet, Abrocitinib Suspension F1, Abrocitinib Suspension F2, Abrocitinib Suspension F3, Abrocitinib Suspension F4
- Keywords
- Abrocitinib, Atopic Dermatitis, Healthy Volunteers, Relative Bioavailability, Taste Assessment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abrocitinib tabletDrug
Single dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours.
Abrocitinib Suspension F1Drug
Single dose of abrocitinib 200 mg oral suspension formulation 1 will be administered after an overnight fast of at least 10 hours.
Abrocitinib Suspension F2Drug
Single dose of abrocitinib 200 mg oral suspension formulation 2 will be administered after an overnight fast of at least 10 hours.
Abrocitinib Suspension F3Drug
Single dose of abrocitinib 200 mg oral suspension formulation 3 will be administered after an overnight fast of at least 10 hours.
Abrocitinib Suspension F4Drug
Single dose of abrocitinib 200 mg oral suspension formulation 4 will be administered after an overnight fast of at least 10 hours.
Abrocitinib Suspension F5Drug
Single dose of abrocitinib 200 mg oral suspension formulation 5 will be administered after an overnight fast of at least 10 hours.
Abrocitinib Suspension F6Drug
Single dose of abrocitinib 200 mg oral suspension formulation 6 will be administered after an overnight fast of at least 10 hours.
FamotidineDrug
Single dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Abrocitinib Tablet | Experimental | Not described Receives: Drug: Abrocitinib tablet |
| Part A: Abrocitinib Suspension F1 | Experimental | Not described Receives: Drug: Abrocitinib Suspension F1 |
| Part A: Abrocitinib Tablet + Famotidine | Experimental | Not described Receives: Drug: Famotidine |
| Part B: Abrocitinib Suspension F1 | Experimental | Not described Receives: Drug: Abrocitinib Suspension F1 |
| Part B: Abrocitinib Suspension F2 | Experimental | Not described Receives: Drug: Abrocitinib Suspension F2 |
| Part B: Abrocitinib Suspension F3 | Experimental | Not described Receives: Drug: Abrocitinib Suspension F3 |
| Part B: Abrocitinib Suspension F4 | Experimental | Not described Receives: Drug: Abrocitinib Suspension F4 |
| Part B: Abrocitinib Suspension F5 | Experimental | Not described Receives: Drug: Abrocitinib Suspension F5 |
| Part B: Abrocitinib Suspension F6 | Experimental | Not described Receives: Drug: Abrocitinib Suspension F6 |
| Part B: Abrocitinib Suspension F1 + Famotidine | Experimental | Not described Receives: Drug: Abrocitinib Suspension F1; Drug: Famotidine |
| Part B: Abrocitinib Suspension F2 + Famotidine | Experimental | Not described Receives: Drug: Abrocitinib Suspension F2; Drug: Famotidine |
| Part B: Abrocitinib Suspension F3 + Famotidine | Experimental | Not described Receives: Drug: Abrocitinib Suspension F3; Drug: Famotidine |
| Part B: Abrocitinib Suspension F4 + Famotidine | Experimental | Not described Receives: Drug: Abrocitinib Suspension F4; Drug: Famotidine |
| Part B: Abrocitinib Suspension F5 + Famotidine | Experimental | Not described Receives: Drug: Abrocitinib Suspension F5; Drug: Famotidine |
| Part B: Abrocitinib Suspension F6 + Famotidine | Experimental | Not described Receives: Drug: Abrocitinib Suspension F6; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 Hours, 5, 10, 20 min after swallowing the suspension on Day 1 of each period.
Secondary outcomes (11)
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.
Measured: 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-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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to follow-up (Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start4 Jun 2021
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903093
- Sponsor's protocol ID
- B7451061
- Status last verified
- Sep 2024
- First submitted
- 21 May 2021
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, CROSSOVER STUDY TO EVALUATE RELATIVE BIOAVAILABILITY OF ABROCITINIB ORAL SUSPENSION AND EFFECT OF AN ACID-REDUCING AGENT ON THE BIOAVAILABILITY OF ABROCITINIB COMMERCIAL TABLET AND TO ASSESS THE TASTE OF ABROCITINIB ORAL FORMULATIONS IN HEALTHY ADULT PARTICIPANTS AGED 18 TO 55 YEARS OF AGE.
- ClinicalTrials.gov ID
- NCT04903093
- Acronym / sponsor ID
- B7451061
- Conditions
- Healthy Volunteers
- Keywords
- Abrocitinib, Atopic Dermatitis, Healthy Volunteers, Relative Bioavailability, Taste Assessment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Posted 14 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Part A: Abrocitinib Tablet | Experimental | Drug: Abrocitinib tablet |
| Part A: Abrocitinib Suspension F1 | Experimental | Drug: Abrocitinib Suspension F1 |
| Part A: Abrocitinib Tablet + Famotidine | Experimental | Drug: Famotidine |
| Part B: Abrocitinib Suspension F1 | Experimental | Drug: Abrocitinib Suspension F1 |
| Part B: Abrocitinib Suspension F2 | Experimental | Drug: Abrocitinib Suspension F2 |
| Part B: Abrocitinib Suspension F3 | Experimental | Drug: Abrocitinib Suspension F3 |
| Part B: Abrocitinib Suspension F4 | Experimental | Drug: Abrocitinib Suspension F4 |
| Part B: Abrocitinib Suspension F5 | Experimental | Drug: Abrocitinib Suspension F5 |
| Part B: Abrocitinib Suspension F6 | Experimental | Drug: Abrocitinib Suspension F6 |
| Part B: Abrocitinib Suspension F1 + Famotidine | Experimental | Drug: Abrocitinib Suspension F1, Drug: Famotidine |
| Part B: Abrocitinib Suspension F2 + Famotidine | Experimental | Drug: Abrocitinib Suspension F2, Drug: Famotidine |
| Part B: Abrocitinib Suspension F3 + Famotidine | Experimental | Drug: Abrocitinib Suspension F3, Drug: Famotidine |
| Part B: Abrocitinib Suspension F4 + Famotidine | Experimental | Drug: Abrocitinib Suspension F4, Drug: Famotidine |
| Part B: Abrocitinib Suspension F5 + Famotidine | Experimental | Drug: Abrocitinib Suspension F5, Drug: Famotidine |
| Part B: Abrocitinib Suspension F6 + Famotidine | Experimental | Drug: Abrocitinib Suspension F6, Drug: Famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abrocitinib tabletSingle dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours. | Drug | Part A: Abrocitinib Tablet |
| Abrocitinib Suspension F1Single dose of abrocitinib 200 mg oral suspension formulation 1 will be administered after an overnight fast of at least 10 hours. | Drug | Part A: Abrocitinib Suspension F1, Part B: Abrocitinib Suspension F1, Part B: Abrocitinib Suspension F1 + Famotidine |
| Abrocitinib Suspension F2Single dose of abrocitinib 200 mg oral suspension formulation 2 will be administered after an overnight fast of at least 10 hours. | Drug | Part B: Abrocitinib Suspension F2, Part B: Abrocitinib Suspension F2 + Famotidine |
| Abrocitinib Suspension F3Single dose of abrocitinib 200 mg oral suspension formulation 3 will be administered after an overnight fast of at least 10 hours. | Drug | Part B: Abrocitinib Suspension F3, Part B: Abrocitinib Suspension F3 + Famotidine |
| Abrocitinib Suspension F4Single dose of abrocitinib 200 mg oral suspension formulation 4 will be administered after an overnight fast of at least 10 hours. | Drug | Part B: Abrocitinib Suspension F4, Part B: Abrocitinib Suspension F4 + Famotidine |
| Abrocitinib Suspension F5Single dose of abrocitinib 200 mg oral suspension formulation 5 will be administered after an overnight fast of at least 10 hours. | Drug | Part B: Abrocitinib Suspension F5, Part B: Abrocitinib Suspension F5 + Famotidine |
| Abrocitinib Suspension F6Single dose of abrocitinib 200 mg oral suspension formulation 6 will be administered after an overnight fast of at least 10 hours. | Drug | Part B: Abrocitinib Suspension F6, Part B: Abrocitinib Suspension F6 + Famotidine |
| FamotidineSingle dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions. | Drug | Part A: Abrocitinib Tablet + Famotidine, Part B: Abrocitinib Suspension F1 + Famotidine, Part B: Abrocitinib Suspension F2 + Famotidine, Part B: Abrocitinib Suspension F3 + Famotidine, Part B: Abrocitinib Suspension F4 + Famotidine, Part B: Abrocitinib Suspension F5 + Famotidine, Part B: Abrocitinib Suspension F6 + Famotidine |
Primary outcome
AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet
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.
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
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Number of Participants With Treatment-Emergent Adverse Event
Time frame: Baseline up to follow-up (Day 36)
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Time frame: Baseline up to follow-up (Day 36)
Number of Participants With Clinically Significant Vital Sign Values
Time frame: Baseline up to follow-up (Day 36)
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values
Time frame: Baseline up to follow-up (Day 36)
Number of Participants With Nausea AEs
Time frame: Baseline up to follow-up (Day 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abrocitinib tablet, Abrocitinib Suspension F1 and Abrocitinib Suspension F2 in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCinf of Abrocitinib Following the Administration of Abrocitinib Commercial Tablet, Abrocitinib Oral Suspension Formulation 1 or Famotidine Plus Abrocitinib Commerical Tablet (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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.