Investigation of the safety, tolerability and pharmacokinetics of Cannabidiol in Healthy Volunteers

Phase 1

Completed

• Conditions: Severe Intractable Epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12618001424291
• Lead Sponsor: Victorian State Government

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-27
• Study Completion: 2018-11-02
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Male or females aged between 18 - 49 years (inclusive);
2.Body mass index between 18 and 30 kg/m2 (inclusive);
3.Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen, Hepatitis C Virus and Human Immunodeficiency Virus;
4.Negative screen for drugs of abuse and alcohol pre-dose on Day -1;
5.Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the results are deemed as not clinically significant by the investigator
6.Be in general good health without clinically significant medical history;
7.Ability to provide written informed consent;
8.Willing and able to follow study instructions and likely to complete all study requirements;
9.Females of childbearing potential must agree to use an established oral, injected or implanted hormonal method of contraception throughout the study (Screening to Day 15) and for 90 days after receiving the study drug.
10. Males must agree to use adequate methods of contraception throughout the study (Screening to Day 15) and for 90 days after receiving study drug, excluding sterilized males (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)
11.Suitable venous access.

Exclusion Criteria

1.Positive screening result for cannabis use;
2.Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products (including e-cigarettes) within 2 months prior to screening; cotinine (nicotine) test to be performed at screening;
3.History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months prior to screening;
4.Use of prescription or over the counter medications within 7 days of investigational product administration, except for hormonal contraception, simple analgesics such as paracetamol, oral non-steroidal anti-inflammatory drugs and vitamins unless approved by the sponsor medical monitor and study doctor;
5.Consumption of grapefruit, grapefruit juice and Seville oranges within 1 week prior to study drug dose or the use of CYP3A inducers/inhibitors within 2 weeks prior to study drug dose, until completion of the study (Day 15 visit). Study doctor will advise what these inducers/inhibitors are..
6 Standard donation of blood within 30 days of investigational product administration;
7.Participation in any investigational drug study within 30 days prior to screening;
8.Females who are pregnant or breastfeeding;
9.Clinically significant (as judged by the investigator) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the study unit;
10.Anticipated need for surgery or hospitalisation during the study;
11.History of brady- or tachy-dysrhythmias;
12. History of heart failure or heart disease;
13. Sensitivity to CBD;
14.Allergy to soybeans or any of the excipients in the IP or placebo preparation.
15.Any condition, which in the investigator’s opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject’s participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified