Dermatitis, Atopic Clinical Trial
Official title:
A PHASE 1, OPEN LABEL, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF A COMMERCIAL TABLET FORMULATION OF PF-04965842 RELATIVE TO THE PHASE III TABLET FORMULATION UNDER FASTING CONDITIONS AND THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF THE COMMERCIAL TABLET FORMULATION IN HEALTHY PARTICIPANTS
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
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.
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