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NCT02609139
A Phase 1, Open Label, Single-Dose, Within Cohort Randomized, 2-Way Crossover Study To Evaluate The Pharmacokinetics Of A Modified Release Formulation Of Pf-06650833 Under Fasting And Fed Conditions In Healthy Adult Subjects
Completed
Phase 1
Last updated 6 May 2016
What this trial tests
Phase 1 trial testing PF-06650833 in Healthy in 18 participants. Completed in 1 February 2016.
Timeline
1 November 2015
Primary endpoint
1 February 2016
1 February 2016
1 February 2016
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 18 |
| Start date | 1 November 2015 |
| Primary completion | 1 February 2016 |
| Estimated completion | 1 February 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PF-06650833 — full drug profile →
- PF-06650833 — full drug profile →
- PF-06650833 — full drug profile →
- PF-06650833 — full drug profile →
- PF-06650833 — full drug profile →
- PF-06650833 — full drug profile →
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.
-
Plasma pharmacokinetic parameters of PF-06650833
Time frame: Baseline to up to Day 14 (0 to +1) postdose
Maximum plasma concentration (Cmax) of PF-06650833 -
Plasma pharmacokinetic parameters of PF-06650833
Time frame: Baseline to up to Day 14 (0 to +1) postdose
Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration (AUClast) of PF-06650833 -
Plasma pharmacokinetic parameters of PF-06650833
Time frame: Baseline to up to Day 14 (0 to +1) postdose
Area under the plasma concentration versus time curve from time zero extrapolated to infinite time (AUCinf) of PF-06650833 (if data permit) -
Plasma pharmacokinetic parameters of PF-06650833
Time frame: Baseline to up to Day 14 (0 to +1) postdose
Dose-normalized maximum plasma Cmax (Cmax(dn)) of PF-06650833 -
Plasma pharmacokinetic parameters of PF-06650833
Time frame: Baseline to up to Day 14 (0 to +1) postdose
Dose-normalized area under the plasma concentration versus time curve from time zero to the time of the last quantitfiable concentration (AUClast(dn)) of PF-06650833 -
Plasma pharmacokinetic parameters of PF-06650833 (if data permit)
Time frame: Baseline to up to Day 14 (0 to +1) postdose
Dose-normalized area under the plasma concentration versus time curve from time zero extrapolated to infinite time (AUCinf(dn)) of PF-06650833 (if data permit)
Sponsor's own description
This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted and high fat meal fed conditions in healthy subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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 -
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
Verify or expand the search:
- PubMed search for NCT02609139
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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- NCT04413617 — TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS · Phase 2 · completed
- NCT04092452 — A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Sup · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02609139 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer
- Last refreshed: 6 May 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02609139.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing