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.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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

Detailed description: 
      This is a Phase 1 randomized study in healthy participants to estimate the relative
      bioavailability of abrocitinib oral suspension (Test formulation) compared to commercial
      abrocitinib tablet (Reference formulation) under fasted condition. The effect of an
      acid-reducing agent on the pharmacokinetics of the commercial tablet formulation will be
      evaluated by administering abrocitinib 200 mg commercial tablet with famotidine 40 mg, as an
      acid-reducing agent. Assessment of taste and palatability of six different abrocitinib
      suspension formulations will also be performed. This study consists of 2 parts, as listed
      below:

      Part A

      Part A of the study will be an open label, randomized, single dose, crossover, 3-treatment, 6
      sequence, 3-period design in healthy male and/or female adult participants (18-55 years).
      Healthy participants will be screened within 28 days prior to the first administration of the
      study intervention to confirm that they meet the participant selection criteria for the
      study. Eligible participants will be admitted to the CRU on Day -1 and will be confined in
      the CRU until discharge, on Day 2 of Period 9 in Part B, after completing both Parts A and B
      of the study. In Part A, participants will be randomized to receive one of the following: a
      single 200 mg dose of abrocitinib commercial tablet (Treatment A), a single 200 mg dose of
      abrocitinib oral suspension formulation 1 (Treatment B), or famotidine (40 mg) administered
      120 minutes before a single 200 mg dose of abrocitinib commercial tablet (Treatment C). All
      participants will be fasting for at least 10 hours before taking abrocitinib.

      Part B

      Part B will be a single-blind, randomized, 6-period, crossover study in healthy male and/or
      female adult participants (18-55 years). For any new healthy participants joining Part B
      only, screening will be performed within 28 days prior to the first administration of the
      study intervention to confirm that they meet the participant selection criteria for the
      study. New participants enrolled in Part B only will be admitted to the CRU on Day -1 and
      will be confined in the CRU until discharge, which is Day 2 of Period 9. On Day 1 of each
      treatment period under fasted conditions, participants will receive a famotidine tablet (40
      mg with 240 mL of room temperature water) administered 120 minutes before a single 200 mg
      dose of abrocitinib oral suspensions (Formulations 1 to 6) or administered a single 200 mg
      dose of abrocitinib oral suspension alone (Formulations 1 to 6), after a fast of at least 10
      hours before abrocitinib administration.
    

Intervention name(s): Abrocitinib tablet; Abrocitinib Suspension F1; Abrocitinib Suspension F2; Abrocitinib Suspension F3; Abrocitinib Suspension F4; Abrocitinib Suspension F5; Abrocitinib Suspension F6; Famotidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours.; Single dose of abrocitinib 200 mg oral suspension formulation 1 will be administered after an overnight fast of at least 10 hours.; Single dose of abrocitinib 200 mg oral suspension formulation 2 will be administered after an overnight fast of at least 10 hours.; Single dose of abrocitinib 200 mg oral suspension formulation 3 will be administered after an overnight fast of at least 10 hours.; Single dose of abrocitinib 200 mg oral suspension formulation 4 will be administered after an overnight fast of at least 10 hours.; Single dose of abrocitinib 200 mg oral suspension formulation 5 will be administered after an overnight fast of at least 10 hours.; Single dose of abrocitinib 200 mg oral suspension formulation 6 will be administered after an overnight fast of at least 10 hours.; Single dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions.
Intervention MeSH terms: Famotidine; Abrocitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abrocitinib; Atopic Dermatitis; Healthy Volunteers; Relative Bioavailability; Taste Assessment