The buccal administration of a NanoCelle™ Cannabidiol formulation to healthy volunteers: a pharmacokinetic, safety and tolerability exploratory pilot study.

Phase 1

Completed

• Conditions: The Investigational Product may be indicated for anxiety; The Investigational Product may be indicated for mood symptoms; The Investigational Product may be indicated for insomnia; The Investigational Product may be indicated for the treatment of inflammatory pain; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12617001491358
• Lead Sponsor: Medlab Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-23
• Study Completion: 2019-04-06
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1)Participants greater or equal to 18 years of age at time of entry on the study;
2)Cognitive ability to understand informed consent process and to give and sign informed consent to the experimental treatment;
3)Participants agree to undergo insertion of an indwelling cannula once for approximately 48 hours with multiple blood draws;
4)Participants agree to adhere to the study protocol;
5) No history of illicit drug use (e.g., including but not limited to natural or synthetic cannabinoid compounds);
6)No history of any chronic diseases;
7)Agree to not driving a car for at least 7 days post administration of the final dose of the IP on Day 2.

Exclusion Criteria

1)Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs;
2)Current or previous allergies or allergic responses to herbal medicines of any kind;
3)Active substance abuse (alcohol or drug dependency);
4)The current use of any illicit drugs (e.g., cannabis in any form);
5)Pregnant or nursing an infant;
6)Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant;
7)Elevated liver enzymes 2x normal limits;
8)The current use of any dietary and herbal supplements;
9)The current use of any over-the-counter or prescription medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome, safety and tolerability: - Demographic data - Medical History - Concomitant medications - ECG - Vital Signs - Blood pathology: FBC, Urea, lipids, electrolytes and creatinine and LFTs - Urine THC testing, Adverse events monitoring and recording.<br>[- Demographic data: screening<br>- Medical History: screening<br>- Concomitant medications: throughout study<br>- ECG: baseline and 24 hours<br>- Vital Signs: throughout study<br>- Blood pathology: FBC, Urea, lipids, electrolytes and creatinine and LFTs: screening and 24 hours<br>- Urine THC testing: screening and 24 hours<br>- Adverse events monitoring and recording: throughout study<br>]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic properties of the Investigational Product:<br>- Drug absorption, distribution, metabolism and excretion time.<br>- Drug Half-life and peak concentration [Blood draws on Day 1: at baseline (0), 15, 30, 60, 90, 120, 180, 240, 360, and 420 min and 24 hours (via intravenous cannula inserted in a vein in the arm or venepuncture) post administration of the IP. Day 2: 30, 60, 90, 120, 180, 240, 360, 420 minutes (7 hours), 12 hours and at 24 hours post administration of the IP]