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.

NCT04903093 | Completed Phase 1 Results FDA Drug

• 1 other identifier: B7451061
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of 2 parts: Part A is to estimate the relative bioavailability of a single 200 mg dose of abrocitinib oral suspension (Test formulation) compared to the commercial abrocitinib tablet (200 mg) (Reference formulation). The effect of an acid-reducing agent on the pharmacokinetics of abrocitinib and its metabolites will also be evaluated by administering abrocitinib 200 mg commercial tablet with or without famotidine 40 mg, as an acid-reducing agent. Part B is to assess the taste and palatability of six different abrocitinib oral suspension formulations. Additionally, the safety and tolerability of abrocitinib tablet (in Part A) and abrocitinib oral suspension formulations (in Part B) will be assessed when given with or without famotidine 40 mg once daily.

Conditions

Healthy Volunteers

Keywords

Abrocitinib; Atopic Dermatitis; Healthy Volunteers; Relative Bioavailability; Taste Assessment

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

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

  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

  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

  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

  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

  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.

Study Arms (15)

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

Interventions

Abrocitinib tablet DRUG

Single dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours.

Part A: Abrocitinib Tablet

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.

Part A: Abrocitinib Suspension F1; Part B: Abrocitinib Suspension F1; Part B: Abrocitinib Suspension F1 + Famotidine

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.

Part B: Abrocitinib Suspension F2; Part B: Abrocitinib Suspension F2 + Famotidine

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.

Part B: Abrocitinib Suspension F3; Part B: Abrocitinib Suspension F3 + Famotidine

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.

Part B: Abrocitinib Suspension F4; Part B: Abrocitinib Suspension F4 + Famotidine

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.

Part B: Abrocitinib Suspension F5; Part B: Abrocitinib Suspension F5 + Famotidine

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.

Part B: Abrocitinib Suspension F6; Part B: Abrocitinib Suspension F6 + Famotidine

Famotidine DRUG

Single dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions.

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C virus antibody (HCVAb).
• Other acute or chronic medical or psychiatric condition including recent (within the past year).
• Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) or visible rash present during physical examination.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
• A positive urine drug test.
• Selected laboratory abnormalities.
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
• History of tuberculosis (TB) (active or latent).
• Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
• Pregnant female participants; breastfeeding female participants; female participants of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
• History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

abrocitinib; Famotidine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part A: open label / Part B: single-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: June 4, 2021
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)