PF-06409577 Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 890

Clinical Trials

PF-06409577 has a brief clinical trial profile, with 2 Phase 1 clinical trials currently on record in public registries. Conducted by the industry sponsor Pfizer, these early-stage clinical studies were designed to evaluate the safety, tolerability, and pharmacokinetic properties of single ascending oral doses in healthy volunteers. The recruitment status for these Phase 1 investigations is documented as terminated, indicating that clinical testing was halted prior to completion. Consequently, no further clinical trials involving healthy subjects or specific patient populations have been conducted to date.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02286882	TERMINATED	Healthy	Pfizer	2014-11	PHASE1
NCT02286882	Terminated	Healthy	Pfizer	2014-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2015-07-20)

Check the PF-06409577 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-06409577 functions as a potent, orally bioavailable activator of AMP-activated protein kinase (AMPK) that targets and stimulates the α1β1γ1 heterotrimeric complex, thereby promoting downstream cellular energy homeostasis signaling pathways and suppressing anabolic lipid synthesis. By modulating cellular metabolic flux and restoring energy balance, this targeted AMPK activation mechanism provided the physiological basis for its evaluation in Phase 1 clinical trials assessing safety, tolerability, and pharmacokinetics in healthy subjects.

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>).