Clinical Trials

Multiple clinical trials sponsored by Pfizer have evaluated PF-06282999 exclusively in Phase 1 studies involving healthy volunteers. These investigations, which encompassed single- and multiple-dose escalation as well as crossover designs, assessed the compound's safety, tolerability, pharmacokinetics, and pharmacodynamics. Overall, recruitment across these trials was reported as either completed or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01965600 TERMINATED
Healthy
Pfizer
 2014-03 PHASE1
NCT01965600 Terminated
Healthy
Pfizer
 2014-03 Phase 1
NCT01707082 COMPLETED
Healthy
Pfizer
 2012-10 PHASE1
NCT01626976 COMPLETED
Healthy
Pfizer
 2012-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2016-08-02)

Check the PF-06282999 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-06282999 acts as an orally bioavailable, irreversible inactivator of the myeloperoxidase enzyme, binding the active target site to block the catalytic production of hypochlorous acid and downstream reactive oxygen species. This inhibition reduces enzyme-driven oxidative damage and vascular inflammatory responses, providing a mechanistic rationale for its clinical evaluation in Phase 1 trials with healthy volunteers for potential cardiovascular applications.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.