A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers
Daniel Perkins, Juliet Butler, Katherine Ong, Tri-Hung Nguyen, Susan Cox, Barbara Francis, Michelle Mcintosh, Brian Lilley
European Journal of Drug Metabolism and Pharmacokinetics | SPRINGER FRANCE | Published : 2020
BACKGROUND: There is increasing interest in the use of purified cannabidiol (CBD) as a treatment for a wide range of conditions due to its 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 three sequential cohorts (each with six active and two placebo subjects). Cohort 1 received 5 mg/kg CBD or placebo, cohort 2 received 10 mg/kg CBD or placebo (cohort ..View full abstract
This study was supported by the Victorian Department of Health & Human Services (Australia), and this sponsor also provided support for open access to this publication.