None listed
Conditions
Brief summary
To determine the pharmacokinetics and safety of ECs315 wafer in healthy volunteers.
Interventions
A dose of ECs315 WaferiX equivalent to 10 mg CBD sublingually
A dose of ECs315 WaferiX equivalent to 20 mg CBD sublingually
A dose of ECs315 (5%) Oil equivalent to 10 mg CBD sublingually
Sativex® 4 actuations (equivalent to 10 mg CBD, 10.8 mg THC) as oromucosal spray
Cohort 1: receives a single dose of ECs315 WaferiX equivalent to 5 mg CBD sublingually (n=6).
Cohort 2: receives a single dose of each of 10 and 20 mg of WaferiX, 10 mg of Oil and Sativex in a randomised crossover design, with each
A dose of ECs315 WaferiX equivalent to 10 mg CBD sublingually A dose of ECs315 WaferiX equivalent to 20 mg CBD sublingually A dose of ECs315 (5%) Oil equivalent to 10 mg CBD sublingually Sativex® 4 actuations (equivalent to 10 mg CBD, 10.8 mg THC) as oromucosal spray Cohort 1: receives a single dose of ECs315 WaferiX equivalent to 5 mg CBD sublingually (n=6). Cohort 2: receives a single dose of each of 10 and 20 mg of WaferiX, 10 mg of Oil and Sativex in a randomised crossover design, with each dose separated by 3 days (n=12). Cohort 3: A daily dose of ECs315 WaferiX equivalent to 20 mg CBD will be administered sublingually for 5 days (multiple dose) to a cohort of 6 patients. The dose will be administered as 10 mg Waferix twice a day. The investigational products will be administered by site staff. Subjects are required to stay in the centre for the duration of the study.
Sponsors
BOD Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
- Medically healthy, determined by non-clinically significant laboratory profiles, medical history, vital signs, physical examination, 12-lead ECG at screening as deemed by the Principal Investigator and/or Sponsor Medical Monitor. - No history of cardiac disease. - Resting heart rate, as measured by ECG in the range of 40 and 100 bpm inclusive. - No active or chronic diseases/disorders, no history of hospitalization for illness within the six months prior to enrolment into study, and no major surgery within the 6 months prior to enrolment into study. - Must have a body mass index in the range of 18 to 32 kg/m2 inclusive and body weight greater or equal 50 kg. - Females must be non-pregnant, non-lactating, or postmenopausal for at least 1 year (as confirmed by follicle-stimulating hormone [FSH]), or surgically sterile for at least 6 months prior to dosing. - Must be non-smokers for at least six months and/or not on nicotine containing products including Tobacco use (chewing or sniffing) or smoking cessation products prior to enrolment. This includes any form of inhaled tobacco including e-cigarettes. Social smokers who are otherwise healthy may be enrolled if they have not used nicotine-containing products within 2 weeks of dosing and agree to abstain for the duration of the study.
Exclusion criteria
- History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator and/or Sponsor Medical Monitor. - Acute disease state (e.g., nausea, vomiting, diarrhoea) within 7 days of Study Day 1. - Used cannabinoids or a cannabinoid-based medicine within 12 months prior to receiving study medication and willingness to abstain from recreational drug use during the study period. - Admitted alcohol abuse or consumption average of more than 2 standard units per day (a standard unit equals 350 ml of beer, 50 ml of 80-proof alcohol, or one 175 ml glass of wine) or history of alcoholism within the past 2 years. - Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies. - Positive urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, phencyclidine, ecstasy, methamphetamines, methadone and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years. - History of any clinically important severe allergic or anaphylactic drug reaction or known or suspected hypersensitivity to compounds similar to the investigational product. - Family history of long QT-syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death such as coronary artery disease, congestive heart failure or terminal cancer. - History of suicide attempt or suicidal behaviour. Any recent suicidal ideation within the last 12 months (a level of 4 or 5 for any 1 item on the scale), or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at screening and on admission to the clinical unit on Day -1.
Outcome results
None listed