Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
Status:
Completed
Trial end date:
2019-12-14
Target enrollment:
Participant gender:
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