“We’re excited about these encouraging results from our Phase 1 study of AP-CBD/THC as it shows the Accordion Pill platform is well suited to safely deliver CBD and THC with significant improvements in exposure compared with Sativex®,” said Nadav Navon, Ph.D., Chief Operating Officer of Intec Pharma. “We are particularly pleased to see the reduction in THC metabolite, which tells us that the AP-CBD/THC avoided some of the hepatic first-pass metabolism of THC.”
The Phase I trial was a single-center, single-dose, randomized, three-way crossover study to compare the pharmacokinetics, safety and tolerability of two formulations of AP-CBD/THC with Sativex in 21 normal healthy volunteers. Sativex is a commercially available oral buccal spray containing CBD and THC.
The study results showed that AP-CBD/THC had significant improvements in exposure of CBD (290% – 330%) and THC (25% – 50%) compared with Sativex. The median time of peak concentration was 2-3 times longer than Sativex