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 个研究点目标入组 16 人开始时间: 2021年9月2日最近更新: 2022年5月23日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 16

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment

入排标准

年龄范围: 18 Years 至 55 Years（—）
性别: All

入选标准

•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).

排除标准

•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/

研究者

发起方

Avecho Biotechnology

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