A Phase I Clinical Trial comparing Pharmacokinetics of EMD-RX5 Cannabidiol (CBD) capsules to Epidyolex CBD oil in Healthy Volunteers.

A randomised open label, two way crossover study comparing the Pharmacokinetic (PK) characteristics of one 150mg dose of EMD-RX5 Cannabidiol (CBD) capsules with one 150mg dose of Epidyolex CBD oil (100mg/mL) in healthy male and female volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000427774

Enrollment

Registered

2022-03-16

Start date

2022-04-07

Completion date

2022-04-21

Last updated

2022-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a study of EMD-RX5, an experimental new treatment for stress. EMD-RX5 is a cannabidiol (CBD) capsule which is hoped to be absorbed more effectively than other approved CBD products. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. In this study, we are investigating whether EMD-RX5 capsules are safe and how the body breaks down and absorbs the new drug in comparison to approved CBD (Epidyolex).

Interventions

The study will comprise 2 dosing periods of 12 participants. In the first period, 6 participants will be randomised to receive one dose of 150mg (3x50mg) EMD-RX5 CBD capsules. The other 6 participants will be randomised to receive one 150mg dose of Epidyolex oil. During this time PK and safety assessments will be made. Following a washout period of 5-7 days, participants will return to the site for their second and final dosing period. During the second dosing period, participants that received the Epidyolex oil in the first dosing period will receive EMD-RX5 CBD capsules and those that received the capsule in the first dosing period will receive the oil in the second dosing period. PK assessments will be taken up to 24 hours after the study drug administration in each dosing period. Adherence to the dosing regime will be monitored through one-on-one supervised dosing.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

- Healthy adults with BMI between 18-32kg/m2. - Baseline full blood count and blood glucose test within normal limits - Able to comply with study

Exclusion criteria

- Pregnant or lactating females - Medical condition that can cause cognitive deficits, or a clinically significant medical or surgical condition as determined by investigator - Active Inflammatory disease - Any cannabis use within 30 days - Positive Drug or Alcohol test or recent or current history of drug or alcohol abuse - Inability to consume high fat meal - Baseline liver function tests more than 1.5 times upper limit of normal. -Use of prescription medication within 2 weeks of dosing, or use of non-prescription medication (including herbal medicine or dietary supplements) within 1 week of dosing. Excludes oral contraceptives, paracetamol and multi-vitamin.

Outcome results