Australian-based pharmaceutical company AusCann Group Holdings Limited (ASX: AC8) has successfully completed the first clinical study of the company’s orally administered tetrahydrocannabinol (THC) and cannabidiol (CBD) combination using the company’s proprietary Neuvisâ platform of self-emulsifying powder in hard-shell capsules.
The randomised, open-label, cross-over Phase I study evaluated the pharmacokinetics and safety of a single dose in fed healthy volunteers.
The study was managed by the Melbourne-based contract research organisation, Nucleus Network, enrolling 28 volunteers of which 25 subjects completed the study.
The primary endpoints of the study were the assessment of the pharmacokinetics of THC, CBD and the main active metabolite of THC (11-hydroxy-THC), following oral doses of 2.5mg:2.5mg and 10mg:10mg of THC:CBD.
The two study arms received either AusCann’s low dose or high dose THC:CBD hard-shell capsules with cross-over to a pre-formulation oil comparator. There was a 14-day washout period between treatments. All subjects received a standardised meal prior to drug administration.
AusCann’s Chief Medical Advisor, Dr Marc Russo, said that encouragingly, the hard-shell capsule showed a lower peak concentration than the oil-based comparator, which was statistically significant (p<0.05) at the 2.5mg:2.5mg dose level. The total drug exposure (area under the plasma drug concentration-time curve) for the 10mg:10mg capsule was similar to the comparator and to results reported for fed healthy volunteers receiving a comparable dose (10.8mg THC and 10.0mg CBD) of the Therapeutic Goods Administration (TGA)-registered product, Sativexâ1. Being an oral spray, Sativex is designed to have superior pharmacokinetic characteristics through oromucosal absorption that bypasses the gastro-intestinal tract and liver metabolism.
The ratio of CBD to THC drug exposure for the AusCann capsule (0.8) was closer to a 1:1 ratio than the ratio achieved for the comparator (0.7) or reported for the Sativex oral spray (0.6)1. Importantly, the pharmacokinetic parameters from the study align with the literature, enabling potential extrapolation of published data to AusCann’s proprietary hard-shell capsules.
“Some formulations peak too fast, causing side effects, and then do not remain in the blood stream for long enough, which increases the number of doses a patient requires per day,”
Dr Russo said.
“This increases the cost for patients and decreases compliance. Having a pharmacokinetic curve that is optimised to an appropriate peak level with a more sustained duration, as was evident from this study with AusCann’s capsules, should translate to improved outcomes and reduced side effects for patients.”