A Phase 1, Randomised, Placebo-controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers

Abstract

Background There is increasing interest in the use of purified cannabidiol (CBD) as a treatment for a wide range of conditions, due to reported anti-inflammatory, anxiolytic, antiemetic and anticonvulsant properties. Objective The objective of this study was to assess the safety, tolerability, and pharmacokinetics of a single ascending dose of a new lipid-based oral formulation of CBD in healthy volunteers after a high fat meal. Methods A total of 24 eligible healthy volunteers (aged 18 – 48 years) were randomised to one of 3 sequential cohorts (each with 6 active + 2 placebo subjects) to receive 5 mg/kg CBD or placebo (cohort 1), 10 mg/kg CBD or placebo (cohort 2) or 20 mg/kg CBD or pla..