Ketohexokinase inhibitor 1 Clinical Trials

Size	Price	Qty
1mg	USD 190
5mg	USD 570

Clinical Trials

Pfizer has sponsored several completed Phase 1 clinical trials for Ketohexokinase inhibitor 1 to evaluate its safety, tolerability, and pharmacokinetics. These early-stage studies investigated single or multiple oral doses across diverse cohorts, including healthy participants, individuals with hepatic impairment, and patients with non-alcoholic fatty liver disease. Together, these evaluations establish the foundational pharmacokinetic and clinical safety profile of this targeted inhibitor.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04427917	Completed	Healthy	Pfizer	2020-11-24	Phase 1
NCT04193436	Completed	Hepatic Impairment\|Healthy Participants	Pfizer	2020-01-21	Phase 1
NCT02974374	Completed	Non-alcoholic Fatty Liver Disease	Pfizer	2016-10	Phase 1

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

Check the Ketohexokinase inhibitor 1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ketohexokinase inhibitor 1 potently inhibits ketohexokinase isoforms C and A, blocking the initial rate-limiting step of hepatic fructose phosphorylation and suppressing downstream fructolysis and de novo lipogenesis. By preventing intracellular lipid accumulation and cellular metabolic stress, this targeted inhibition directly addresses hepatic metabolic dysfunction relevant to non-alcoholic fatty liver disease and hepatic impairment.

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>).