A study to evaluate the effect of food on the pharmakokinetics and cardiac function in male and female healthy volunteers who have been administered cannibidiol.

A double-blind, randomized, two-period, two treatment, fixed sequence, crossover (fed versus fasted) study. The Cannabidiol (CBD) and placebo will be administered orally as a liquid solution according to the pre-determined randomization scheme. The final administration volume for all CBD doses and placebo will be supplied as 6mL/vial (fill volume), where the deliverable volume is 5mL, wherein 4 vials will constitute one dose of either 600mg CBD or 1200mg CBD or placebo Screening: Days -28 to -2 Fasted Period Randomization: Days -1 or 1 PK sampling & Holter monitoring/Single Dose Administration: Days 1, 9 and 15 1st Washout: Days 2-8 Multiple Dosing (two times per day): Days 10 to 15 2nd Washout: Days 16 to 29 Fed Period - Subjects crossover to fed period (during Fed period subjects will receive a high calorie meal in the morning, 30 minutes prior to administration of the Investigational Medicinal Product (IMP) Pharmacokinetic (PK) sampling & Holter monitoring/Single Dose Administration: Days 30, 38 and 44 3rd Washout: Days 31 to 37 Multiple Dosing Administration (two times a day): Days 38-44 End of Study: Day 45 Safety Follow Up: Day 51 (phone call) Fasted state: Beginning on Day 1 with a single dose administration. A 7-day washout period will follow. On Days 9 and 15 subjects will be administered the total daily dose (i.e. 600mg, 1200mg or placebo) as a single morning dose after being fasted for a minimum of 10 hours. On Days 10-14 subjects will be administered IMP or placebo twice-daily (BID) with the first daily dose administered post a minimum of 10 hour fast. At least 8 hours should lapse between multiple daily doses (±2 hours). The second daily dose should be administered post a minimum 2-hour fast.14-day washout period will commence post Day 15. Fed state: On day 30 subjects will be administered a high calorie/high fat meal 30 minutes prior to receiving a single dose of CBD or placebo. This will be followed by a 7-day washout period. On day 38 subjects will receive a high calorie/high fat meal 30 minutes prior to Cannabidiol (CBD) or placebo dosing. On Days 30 and 38 subjects will receive a single morning dose of IMP or placebo (i.e. 600mg, 1200mg or placebo) 30 minutes after starting the consumption of a high calorie/high fat meal. and continue on this meal and dosing regimen for 7 days (until day 44). The Phase 1 unit will provide subjects with written email/text reminders of fasting requirements and periods. This is also well documented in the participant information and consent form.