drugset / Trial / NCT04580797

Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations

NCT04580797

Phase 1 Completed 36 enrolled Pfizer
RandomizedCrossoverDouble-blindOther

Summary

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.

Timeline

Start
2020-10-02
Primary completion
2021-01-11
Completion
2021-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Brepocitinib Small molecule Oral

Indications

No indication recorded.