drugset / Trial / NCT04065633

Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation

NCT04065633

Phase 1 Completed 46 enrolled Pfizer
RandomizedCrossoverOpen-labelOther

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

Timeline

Start
2019-07-18
Primary completion
2019-12-14
Completion
2019-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Abrocitinib Small molecule 200 mg

Indications