Phase I, open label, randomised three-way cross over study to determine the safety and pharmacokinetics of CBD administered as a single oral dose to healthy volunteers

Phase 1

Completed

• Conditions: Insomnia; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12622000961741
• Lead Sponsor: Bod Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-07
• Study Completion: 2022-09-06
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

•Male and females 18 – 30 years old
•BMI 18.5-30 kg/m2
•Otherwise healthy
•Able to provide informed consent
•Agree not to significantly change current diet/exercise
•Agree not to use over-the-counter drugs (except oral contraceptive pill) or other dietary supplements (including CBD) during the study period

Exclusion Criteria

•Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)*
•Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
•Currently taking any prescription medication (other than for contraception e.g., oral contraceptive pill)
•Active smokers and nicotine or drug use (drug test will be administered)
•Chronic past and/or current alcohol use (>14 alcoholic drinks week)
•Allergic to any of the ingredients in active or placebo formula
•Diagnosed with serious mood disorders (such as depression and bipolar disorder)
•People suffering any neurological disorders such as MS
•Pregnant or lactating woman
•Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
•Participants who have participated in any other clinical trial during the past 1 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to measure total absorption of CBD using the concentration of blood samples [pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 hours post-administration of each of the three treatments. ]

Secondary Outcome Measures

Name	Time	Method
to measure the pharmacokinetics of CBD and its metabolites including AUC, T1/2, Tmax and Cmax using blood samples. [pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 hours post-administration of each of the three treatments. ];to assess the safety and tolerability of CBD softgel capsules assessed by regular monitoring of patients and ask if any unusual effects were experienced after their treatment at each visit. <br>the severity of adverse events is assessed as mild, moderate or severe. The number of adverse events as mild, moderate or severe will be collected and reported. [at the baseline visit and during the blood collection at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 hours post-administration of each of the three treatments. ]