A Phase I, open label, randomised, single dose, two-way crossover study in healthy volunteers to determine the pharmacokinetics of two doses of an oral cannabidiol soft-gel capsule.

Avecho Biotechnology0 sites16 target enrollmentSeptember 2, 2021

ConditionsInsomnia Neurological - Other neurological disorders

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Insomnia
Sponsor: Avecho Biotechnology
Enrollment: 16
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 2, 2021

End Date

October 29, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Avecho Biotechnology

Eligibility Criteria

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\.