US-based biopharmaceutical firm Cingulate Therapeutics has begun dosing healthy volunteers in the Phase I proof-of-concept trial of its product candidate CTX-1301.
Based on flexible core tableting technology known as OralogiK, CTX-1301 uses a target product profile to provide quicker onset, last for a complete active day and reduce the afternoon crash with less impact on sleep and appetite.
OralogiK was developed by Cingulate’s development partner Bio-Images Drug Delivery (BDD Pharma).
According to Cingulate Therapeutics chairman and CEO Shane Schaffer, the technology combines different layers of immediate, delayed and sustained release drugs in a single tablet intended to deliver precise dose at the right time, based on the requirements of the attention deficit / hyperactivity disorder (ADHD) patients.
The randomised, three-arm, open-label cross-over trial is currently being conducted by BDD Pharma and will assess CTX-1301’s in-vivo pharmacokinetic behaviour over four weeks.
The trial will use gamma scintigraphic imaging along with standard assays to examine the absorption, distribution, metabolism and excretion of the product.
Schaffer further added: “This study intends to demonstrate the ability of our technology to achieve the Target Product Profiles in advance of filing separate investigational new drug (IND) applications with the US Food and Drug Administration by the end of this year."
The data from various in-vitro sets is reported to show the required triphasic controlled-release functionality of the product.
BDD CEO Dr Carol Thomson said: "We are delighted to be working with Cingulate Therapeutics to develop this exciting new product, which is now undergoing clinical evaluation using our pharmaco-scintigraphic capabilities.
“The OralogiK technology is uniquely positioned to deliver the tri-phasic release profile required of the CTX-1301 and CTX-1302 products."
The results from the proof-of-concept trial are expected to be available in the third quarter of this year.