A comparison of cannabis medicines containing Cannabidiol (CBD) in healthy males

Phase 1

Active, not recruiting

• Conditions: Chronic pain; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12623000944639
• Lead Sponsor: The University of Newcastle, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1. Healthy male participants aged between 18 and 40 years,
2. Ability to communicate adequately with the investigator or their representatives
3. Ability to understand and agreement to comply with the study requirements and assessments
4. Provision of written informed consent
5. Non-smokers, non-vaper
6. Negative alcohol breath test results
7. Body Mass Index ranged between 18.5-30 kg/m2
8. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 40 to 100 bpm
9. Laboratory results within normal range or clinically non-significant (FBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results is negative (amphetamine, benzodiazepine, cannabinoid, cocaine, opiate),
10. He and his female partner will use contraception during the study and at least 7 days after the study.
11. Willing to fast overnight from 9pm, three times, prior to each treatment

Exclusion Criteria

1. Who are not suitable to any of inclusion criteria.
2. Participants suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator’s judgement,
3. Who have known allergy for cannabidiol and/or any other ingredients of the products
(excipients),
4. History of difficulty of swallowing.
5. Participants who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug.
6. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal (and/or GI Surgery), renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria.
7. Use of any drug including over-the-counter (OTC) that may have an interaction with Cannabidiol within 2 weeks prior to each treatment
8. History of drug or alcohol abuse, defined as diagnosed substance abuse disorder.
9. Use of any Cannabis or other illicit drug in past month, confirmed by negative drug screen
10. Regular use of more than 2 units of alcohol per day or 10 units per week and/or positive
alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25
mL spirits).
11. Participants who have taken any grapefruit or grapefruit juice during 7 days prior to drug
administration, during the study.
12. Participants who have given more than 400 mL blood within the last two months before the first treatment and participants who have participated in any drug research within the last two months before the first treatment.
13. Participants who have a relationship with the study team.

Study & Design

• Study Type: Interventional
• Study Design: Not specified