Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions

Phase 1 Completed 40 enrolled Pfizer

RandomizedCrossoverDouble-blindBasic science

Summary

This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals are to assess the safety, tolerability and blood levels of ascending doses of multiple formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on exposure, in healthy subjects.

Timeline

Start: 2014-09
Primary completion: 2015-06
Completion: 2015-06

Publications

Danto SI, Shojaee N, Singh RSP, Li C, Gilbert SA, Manukyan Z, Kilty I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor, in single and multiple ascending dose randomized phase 1 studies in healthy subjects. Arthritis Res Ther. 2019 Dec 5;21(1):269. doi: 10.1186/s13075-019-2008-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ZIMLOVISERTIB	Small molecule	1 mg	Oral
Subject	ZIMLOVISERTIB	Small molecule	10 mg	Oral
Subject	ZIMLOVISERTIB	Small molecule	500 mg	Oral
Subject	ZIMLOVISERTIB	Small molecule	1000 mg	Oral

Indications

No indication recorded.