Quolet completes phase 1 study of oral, lipid-based CBD in healthy volunteers

Key takeaways:

• The study included 14 healthy individuals who were given standard CBD and a novel, lipid formulation of CBD.
• The lipid formulation achieved significantly higher blood concentrations than standard CBD.

Quolet Industries has announced the completion of a phase 1 study evaluating a novel, lipid formulation of pure CBD as a potential treatment for various psychiatric and neurologic conditions.

According to a company release, researchers at King’s College London partnered with the SEEK group to test whether the bioavailability of oral CBD could be improved through administration in a novel, patented lipid formulation.

The phase 1 clinical trial included 14 healthy individuals who were given a single dose of 1,000 mg CBD — five capsules of 200 mg each — in two separate visits. Participants were given the lipid CBD formulation at the first visit and a standard, CBD-only formulation at the second. At both visits, researchers measured blood levels of CBD and its metabolites at regular intervals, as well as side effects and blood markers of liver function.

According to the release, the area under the curve exposure in the blood was nine times higher with the lipid CBD formulation vs. the standard CBD-only formulation (611 ng·h/mL vs. 67 ng·h/mL), and the maximum concentration was 24 times higher (73 ng/mL vs. 3.1 ng/mL), both of which reached statistical significance.

Further, the time course of CBD and metabolite levels in the blood indicated minimal first-pass liver metabolism of lipid-CBD, the release stated.

“CBD is a very promising candidate novel treatment,” Philip McGuire, PhD, principal investigator and professor at Kings College London, said in the release. “However, only a small proportion of oral CBD is absorbed. Our results indicate that this issue can be addressed by administering CBD in a lipid formulation.”