A phase I study to measure the absorption of cannabidiol (CBD) in healthy volunteers after consumption of an oral CBD soft-gel capsule

Phase 1

Completed

• Conditions: Insomnia; Neurological - Other neurological disorders

• Registration Number: ACTRN12621001181897
• Lead Sponsor: Avecho Biotechnology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-02
• Study Completion: 2021-10-29
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

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

Inclusion Criteria

1.Aged greater than or equal to 18 years and less than or equal to 55 years (inclusive).
2.Participant is free from clinically significant (in the opinion of the Investigator) illness or disease as determined by their medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory determinations.
3.Body Mass Index (BMI) greater than or equal to 18.0 and less than or equal to 27 kg/m2 at Screening.
4.Weight > 50.0 kg at Screening.
5.Adequate venous access in both arms for collection of a number of blood samples.
6.Capable of understanding the purposes and risks of the study and able to provide written informed consent before any study-specific screening procedures are performed.
7.Willing and able to adhere to all protocol requirements.
8.Female participants must be abstinent or agree to use effective contraception (i.e., pill, condom) during the study period (from the time of first check in until completion of the final study visit).
9.Male participants that are not surgically sterile (i.e. vasectomy) must be abstinent or agree to use effective barrier contraception (i.e., condom) during the study period (from the time of first check in until completion of the final study visit).

Exclusion Criteria

1.History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
2.Have a rested systolic blood pressure of < 90 mmHg or > 160 mmHg and/or diastolic blood pressure of < 50 mmHg or > 95 mmHg or radial pulse rate at rest of < 45 beats per minute (bpm) or > 100 bpm at Screening or Check-In (Day -1). Blood Pressure (BP) or heart rate may be re-tested two times in the rested position at intervals of five minutes. The elevation is considered sustained if any values are outside the stated limits after three assessments or judged as clinically significant by the Investigator and the participant may not be enrolled.
3.History of acute or severe bronchial asthma (excluding childhood or exercise induced asthma), diagnosed obstructive sleep apnoea, hypoxia, hypoxaemia, hypercarbia, or other obstructive airway disease or any condition that may increase the risk for respiratory depression.
4.History of neurologic conditions such as seizures or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure.
5.Presence of current psychiatric condition or psychiatric condition requiring pharmacological management within the last two years.
6.A calculated creatinine clearance of < 85 mL/minute at Screening or Check-In (Day -1) according to the equation using Cockcroft and Gault.
7.Liver function tests showing values for ALT or AST > 1.5 times ULN at Screening
8.Evidence or history of clinically significant (in the opinion of the Investigator) other cardiovascular, pulmonary, neurologic or renal disorders or hepatic, gastrointestinal, oral (difficulty swallowing / taking oral medication), haematological, endocrine, or psychiatric impairment/disorders.
9.Have undergone surgery requiring, or have received (for any reason) anaesthetic within 30 days of Day 1.
10.Use of CNS depressants including: opioids, sedative, anxiolytics, hypnotics, neuroleptics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines or cimetidine within 30 days of Day 1.
11.Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritonavir) within 30 days of Day 1.
12.Use of any prescription medication within 14 days of Day 1 and for duration of study, unless approved by both the Investigator and the Medical Monitor (in writing). If necessary, paracetamol (acetaminophen) or ondansetron (or other 5-HT3 receptor antagonist) may be administered with the approval of the Investigator.
13.Use of any over the counter product, herbal product, diet aid, or hormone supplement, with a particular regard to hemp or products containing cannabidiol, within 14 days of Day 1 and for duration of study, unless approved by both the Investigator and Medical Monitor (in writing).
14.Known intolerance, allergy or hypersensitivity reactions to medicinal cannabis.
15.Positive screening test for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
16.Evidence or history of substance or alcohol abuse (drink more than 4 standard units of alcohol per day or >10 standard units per week), including positive results for the urine drugs of abuse test or a positive alcohol breath test at Screening or at Check-In (Day -1).
17.Unwilling or unable to abstain from recreational drug/

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CBD will be quantified in blood samples and used to calculate the following pharmacokinetic parameters for each dose:<br>- Cmax: Maximum observed concentration<br>- tmax: Time to reach the maximum concentration<br>- AUC0-last: Area under the plasma concentration-time curve from the time of the dose administration to the time of the last measurable concentration calculated by the linear up log down trapezoidal method.<br>- AUC0-inf: Area under the concentration-time curve from the time of the dose administration to time infinity calculated by the linear up log down trapezoidal method.<br>- t1/2: Elimination half-life associated with the terminal slope (kel) of the semilogarithmic concentration-time curve, calculated as 0.693/kel.<br>- CL/F: The apparent total clearance.<br>- Vz/F: The apparent total volume of distribution.[For each dosing period, blood samples will be taken at: pre-dose and 0.5, 1, 2, 3, 4, 6, 9, 12, 24 and 48 hours post-dose for the characterisation of the CBD PK]