Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
Brief Summary:
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age.
There are no available pharmacological treatments of cannabis use disorder (CUD).
Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders.
In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast.
AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics .
In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date.
This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.