MK1064 Clinical Trials

Size	Price	Qty
1mg	USD 107
5mg	USD 327

Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by Merck Sharp & Dohme LLC have evaluated the investigational drug MK1064 in human subjects. These studies assessed the candidate's safety, pharmacokinetics, and pharmacodynamics following single-dose administration, as well as its impact on polysomnography parameters in a crossover trial design. Together, these early-phase evaluations established the preliminary safety profile, pharmacokinetic characteristics, and central sleep-modulating activity of this agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02549027	Completed	Polysomnography	Merck Sharp & Dohme LLC	2009-11-06	Phase 1
NCT02549014	Completed	Pharmacokinetics	Merck Sharp & Dohme LLC	2009-07-06	Phase 1

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

Check the MK1064 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK1064 functions as a selective orexin 2 receptor antagonist (2-SORA) with an IC50 of 18 nM, binding directly to the receptor to block downstream wake-promoting neuropeptide signaling cascades. This cellular inhibition suppresses central arousal pathways and promotes sleep, directly supporting its clinical evaluation in polysomnography and pharmacokinetic 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>).