A Phase 1, AME Study of [4-14C]AEF0117 Following a Single Oral Dose in Healthy Male Subjects
Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
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. Approximately 9 %
of those who use cannabis will become addicted. The number goes up to about 1 in 6 among
those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis
daily. The consequences of cannabis abuse in the most prone population (14-25 years of age)
are extremely serious, and may include addiction, altered brain development, poorer
educational outcomes, cognitive impairment, lower income, greater welfare dependence,
unemployment and lower relationship and life satisfaction. 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. The purpose of this research is to study how AEF0117 influences the subjective
effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC
(tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of
cannabis's effects.
This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male
subjects. Potential subjects will be screened to assess their eligibility to enter the study
within 28 days prior to the dose administration. Subjects will be admitted into the study
site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg
containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a
low fat breakfast.