GSK1292263 Clinical Trials

Size	Price	Qty
10mg	USD 197

Clinical Trials

A completed Phase 1 clinical trial sponsored by GlaxoSmithKline evaluated GSK1292263, an investigational agent targeted for the management of Type 2 Diabetes Mellitus. Conducted in healthy adult participants, the study investigated potential pharmacokinetic drug-drug interactions between GSK1292263 and the statins rosuvastatin and simvastatin. Findings from this early-phase research provide critical insights into the compound's safety, tolerability, and metabolic co-administration profile.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01101568	Completed	Diabetes Mellitus Type 2	GlaxoSmithKline	2010-04-14	Phase 1

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

Check the GSK1292263 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK1292263 acts as a selective agonist of G-protein coupled receptor 119 (GPR119), triggering intracellular signaling cascades that promote glucose-dependent insulin secretion from pancreatic beta cells. This enhancement of insulin secretion and peripheral glucose disposal directly underlies its clinical relevance for improving glycemic control in type 2 diabetes mellitus.

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>).