Non-clinical toxicity studies |
---|
- embryo-foetal developmental study |
- pre- and postnatal developmental study |
- juvenile animal toxicity study |
- 2-year carcinogenicity study with gavage |
- 2-year carcinogenicity study in mouse |
- 2-year carcinogenicity study in rat with gavage |
- Potential for chronic liver injury |
- Effect on glomerular filtration rate |
- Pregnancy outcome study |
- QT interval prolongation trial at the maximum tolerable dose |
CBD effect on the pharmacokinetics of: |
- caffeine |
- sensitive CYP2B6 cytochrome P450 |
- sensitive UGP1A9 UDP-glucuronosyltransferase |
Strong CYP3A inhibitor effects on pharmacokinetics of CBD |
Strong 2C9 inhibitor effects on pharmacokinetics of CBD |
Rifampin effects on pharmacokinetics of CBD |
TYPE OF STUDY | RESULTS |
---|---|
- cannabinoid receptors | no significant affinity |
- opioid receptors | no significant affinity |
- tetrad test | no meaningful abuse related signal |
- drug discrimination study | no meaningful abuse related signal |
- self-administration study | no meaningful abuse related signal |
Lennox-Gastaut syndrome Dravet syndrome |
|
- Phase I clinical study | no euphoria or other abuse-related signals |
- Phase II/III studies | could not be evaluated concomitant use of other seizure drugs and limited capacity of patients |
randomized, double blind, placebo-controlled trial | |
subjects: healthy recreational poly-drug users | |
positive control: THC (10, 30 mg), alprazolam (2 mg) | |
negative control: placebo | |
mean DRUG LIKING SCORE | |
lower therapeutic dose: 750 mg/day | not significantly different |
higher therapeutic dose: 1500 mg/day | significantly different (very small increase) |
supra-therapeutic dose: 4500 mg/day | significantly different (very small increase) |
3 days after discontinuation | no withdrawal signs and symptoms |