Dalcetrapib (JTT-705) Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

Multiple clinical trials have investigated dalcetrapib across Phase 1 and Phase 2a evaluations, with all studies reaching completed recruitment status. Early development included a Phase 1 trial sponsored by Hoffmann-La Roche to assess pharmacokinetics in healthy volunteers. Subsequently, a Phase 2a trial sponsored by DalCor Pharmaceuticals, in collaboration with Covance and the Montreal Health Innovations Coordinating Center, evaluated the compound's efficacy in patients with mild to moderate COVID-19.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04676867	Completed	Covid19	DalCor Pharmaceuticals\|The Montreal Health Innovations Coordinating Center (MHICC)\|Covance	2021-01-11	Phase 2
NCT01363999	Completed	Healthy Volunteer	Hoffmann-La Roche	2011-06	Phase 1

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

Check the Dalcetrapib (JTT-705) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dalcetrapib acts as a selective recombinant human cholesteryl ester transfer protein (CETP) inhibitor with an IC50 of 0.2 μM, binding to CETP and inducing a conformational change that disrupts lipid transfer biochemistry to promote pre-β-HDL formation in plasma. This targeted inhibition elevates systemic high-density lipoprotein cholesterol levels and modulates lipid metabolism, establishing the biochemical rationale for its clinical evaluation in healthy volunteers and patients with COVID-19.

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>).