BI-671800 Clinical Trials

Size	Price	Qty
5mg	USD 287
25mg	USD 977

Clinical Trials

Several completed Phase 1 clinical trials sponsored by Boehringer Ingelheim have evaluated the investigational compound BI-671800. Conducted in healthy volunteers as well as patients with asthma and perennial allergic rhinitis, these early-stage studies primarily assessed the safety, tolerability, pharmacokinetics, and metabolism of oral BI-671800 formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01216384	Completed	Asthma\|Rhinitis Allergic Perennial	Boehringer Ingelheim	2010-10	Phase 1
NCT01215773	Completed	Healthy	Boehringer Ingelheim	2010-10	Phase 1
NCT01205373	Completed	Healthy	Boehringer Ingelheim	2010-09	Phase 1

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

Check the BI-671800 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BI-671800 acts as a potent and selective antagonist of chemoattractant receptor-homologous molecule expressed on Th2 cells (DP2/CRTH2), preventing prostaglandin D2 (PGD2) binding and inhibiting receptor-mediated downstream signaling pathways that trigger Th2 cell recruitment and activation. This targeted inhibition suppresses pro-inflammatory mediator release and eosinophilic airway inflammation, providing clinical relevance in the management of allergic inflammatory conditions such as asthma and perennial allergic rhinitis.

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>).