Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A

        -  To measure and compare the amount of study drug in the blood after a single 200 mg dose
           of study drug given as the commercial tablet formulation and the Phase 3 tablet
           formulation under fasting conditions

        -  To measure and compare the amount of study drug in the blood after a single 200 mg dose
           given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under
           fasting conditions

        -  To estimate the effect of food on the amount of study drug in the blood after a single
           200 mg dose of the commercial formulation

      Part B

      • To measure and compare the amount of study drug in the blood after a single 200 mg dose
      given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting
      conditions

      Parts A & B

        -  To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize [break
           down] certain medications)

           o Genotyping is the collection of a small sample of blood that contains your genes

        -  To evaluate the safety and tolerability of the study drug after single 200 mg doses of
           the three different formulations given to healthy participants

        -  To measure the amount of study drug in the blood after single doses of the different
           formulations

        -  To collect exploratory samples for biobanking o Biobanking is the collection and storage
           of blood samples for possible future testing
    

Detailed description: 
      The purpose of this study in healthy participants is to estimate the bioavailability (BA) of
      the commercial formulation of PF-04965842 and a variant formulation with slower dissolution
      relative to the Phase 3 formulation, to demonstrate the bioequivalence (BE) of the commercial
      formulation relative to the Phase 3 formulation, and to estimate the effect of food on the BA
      of the commercial formulation. This study consists of 2 parts: Part A is to estimate the
      relative BA (rBA) of single 200 mg doses of the commercial tablet formulation of PF-04965842
      and a variant formulation of slower dissolution rate compared to the Phase 3 tablet
      formulation. The effect of food on the BA of the commercial tablet formulation will also be
      evaluated. Part B is to establish BE between the Phase 3 and commercial formulations. The
      study will follow a staged approach as the sample size for BE cannot be determined with
      currently available information.

      Therefore, it is proposed to assess the maximum observed concentration (Cmax) and area under
      the curve (AUC) ratios between the Phase 3 and commercial formulations as well as the
      within-participant variability of Cmax and AUC values determined in Part A. Based on the
      results from Part A, the sample size of Part B will be determined and the decision to proceed
      to Part B will be made.
    

Intervention name(s): P3-Fast; Comm-Fast; Vari-Fast; Comm-Fed
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions; 200 mg PF-04965842 commercial tablet formulation under fasted conditions; 200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions; 200 mg PF-04965842 commercial tablet formulation under fed conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1 randomized, open label, single-dose, crossover study in healthy participants to estimate the rBA of the commercial formulation of PF-04965842 (Test formulation 1) and the variant formulation with slower dissolution (Test formulation 2) compared to the Phase 3 formulation (Reference formulation), to demonstrate the BE of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the rBA of the commercial formulation after a single 200 mg oral dose.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phase 1 Bioequivalence Study; Healthy Participants; Estimation of the Effect of Food; Relative Bioavailability