NCT02224651

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Substitution, Crossover, Single Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf 06650833 Delivered In Multiple Formulations In Healthy Subjects Under Fasted And Fed Conditions

Completed Phase 1 Last updated 1 July 2015

What this trial tests

Phase 1 trial testing PF-06650833 in Healthy in 40 participants. Completed in 1 June 2015.

Timeline

1 September 2014

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	40
Start date	1 September 2014
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	1 location across United States

Drugs / interventions tested

• PF-06650833 — full drug profile →
• Placebo
• PF-06650833 — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
  Time frame: Baseline-5 days
• Changes from baseline in vital signs ( blood pressure, pulse rate, respiratory rate and orthostatic blood pressure)
  Time frame: Baseline-5 days
• Changes from baseline in ECG parameters (standard 12 lead ECG and telemetry)
  Time frame: Baseline-5 days
  Quantitative changes in ECG intervals
• Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry (including, cardiac enzymes CK, CK MB and cardiac Troponin I), serum myoglobin, urinalysis
  Time frame: Baseline-5 days

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Toll-like receptor signalling in B cells during systemic lupus erythematosus.
   Fillatreau S, Manfroi B, Dörner T. · · 2021 · cited 229× · PMID 33339987 · DOI 10.1038/s41584-020-00544-4
2. The role of inflammation in autoimmune disease: a therapeutic target.
   Xiang Y, Zhang M, Jiang D, Su Q, et al · · 2023 · cited 104× · PMID 37859999 · DOI 10.3389/fimmu.2023.1267091
3. 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.
   Danto SI, Shojaee N, Singh RSP, Li C, et al · · 2019 · cited 48× · PMID 31805989 · DOI 10.1186/s13075-019-2008-6
4. Emerging interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitors or degraders as therapeutic agents for autoimmune diseases and cancer.
   Feng Y, Chen C, Shao A, Wu L, et al · · 2024 · cited 11× · PMID 39807338 · DOI 10.1016/j.apsb.2024.09.008
5. Blockade of IL-1 family cytokines in the treatment of rheumatoid arthritis.
   Wang K, Luo H, Liu L, Gao H, et al · · 2025 · cited 10× · PMID 40520203 · DOI 10.3389/fphar.2025.1577628
6. Design of a Novel and Selective IRAK4 Inhibitor Using Topological Water Network Analysis and Molecular Modeling Approaches.
   Lee MH, Balupuri A, Jung YR, Choi S, et al · · 2018 · cited 8× · PMID 30501110 · DOI 10.3390/molecules23123136