CONCORD, Mass.– Lennham Pharmaceuticals today announced topline results of the first ever human study of d9-caffeine. The study was conducted to compare the single-dose pharmacokinetics of caffeine versus d9-caffeine and their corresponding metabolites in healthy adult volunteers.
“Caffeine is a ubiquitously consumed product with many benefits, but is limited by a short half-life and Cmax and metabolite-related side effects,” said Bradford C. Sippy, Founder and CEO of Lennham. “d9-Caffeine potentially addresses these limitations, while retaining the beneficial properties of caffeine. We believe that d9-caffeine has significant potential as a food or energy drink ingredient at low doses, and as a pharmaceutical product at higher doses. We intend to rapidly advance our differentiated version of caffeine for food ingredient, energy drink, and pharmaceutical applications.”
The study was a randomized, controlled, double-blind, two-part, two-period crossover design. Unlabeled caffeine or d9-caffeine at two dose levels were administered with blood samples collected before and up to 48 hours after administration. Plasma levels for caffeine, d9-caffeine and their respective primary metabolites were analyzed.
d9-Caffeine exhibited a similar time to maximum plasma concentration (Tmax), a higher peak plasma concentration (Cmax) and a 4-fold higher total exposure (AUC) than a similar dose of caffeine. The three active metabolites of d9-caffeine demonstrated a lower Cmax and lower exposure relative to their un-deuterated counterparts. Results were consistent in the low and high dose comparison. Slower metabolizers of caffeine demonstrated a lower relative increase in exposure to d9-caffeine than rapid metabolizers. Both products were well tolerated. No adverse events for insomnia were reported during the study.
Lennham plans to present the results of this study at the International Society of Sports Nutrition’s annual meeting in St. Petersburg, FL on June 11, 2021 and to submit the results of the study for publication in a peer-reviewed scientific journal.
Lennham holds two broad United States patents on d9-caffeine as a food ingredient, U.S. Patent Nos. 10,582,716 and 10,765,130, which expire in 2039, and multiple pending applications.
