Choline Fenofibrate Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several completed Phase 1 clinical trials, primarily sponsored by industry leaders Abbott and AstraZeneca, have evaluated the lipid-regulating compound choline fenofibrate (ABT-335). These early-phase investigations focused on assessing the pharmacokinetic properties, systemic exposure, bioavailability, and safety profile of the drug across healthy volunteer cohorts and populations with dyslipidemia or renal insufficiency.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00839293	Completed	Healthy	Abbott	2009-02	Phase 1
NCT00808678	Completed	Healthy	AstraZeneca	2008-12	Phase 1
NCT00826358	Completed	Healthy	AstraZeneca	2008-11	Phase 1
NCT00585143	Completed	Dyslipidemia Renal Insufficiency	AstraZeneca	2008-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Choline fenofibrate selectively binds to and activates peroxisome proliferator-activated receptor alpha (PPARα), which alters nuclear transcription factor activity to stimulate lipid β-oxidation and downregulate hepatic triglyceride synthesis. This biochemical cascade enhances lipoprotein lipase-mediated clearance of triglyceride-rich particles and increases high-density lipoprotein synthesis, thereby providing the therapeutic basis for managing dyslipidemia and associated metabolic conditions evaluated in clinical trials.

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>).