A Phase 1 Study to Assess the Safety and Pharmacokinetics of Novel Cannabidiol (CBD) Soft-gel Capsule Formulation (NW300EMCBD) in Healthy Subjects
The purpose of this study is to test a new formulation of cannabidiol (CBD) to see how it is processed in the body and how safe it is for healthy volunteers. CBD is a compound found in the cannabis plant that has shown potential to help treat various medical and mental health conditions. While there is already an approved CBD-based drug that is used for epilepsy in the UK, called Epidyolex, most CBD formulations have poor absorption when taken orally, reducing their effectiveness and often requiring higher doses. NW PharmaTech has developed a new CBD formulation aimed at improving absorption and processing by the body. This study will assess the absorption, safety, and tolerability of two different doses (600 mg and 900 mg) of the new formulation and will compare them with Epidyolex (dosed as per approved label). All participants will receive each of the following three dosing regimens in a randomised order across three separate experimental periods, with each period separated by a 25 day washout period, which ensures that the drug from one dosing regimen is fully cleared from your body before the next dosing regimen begins. Regimen A: 600 mg of the new CBD formulation (NW300EMCBD) administered orally Regimen B: 900 mg of the new CBD formulation (NW300EMCBD) administered orally Regimen C: 25 mg/kg Epidyolex solution (2 x 12.5 mg/kg doses separated by 12 hours) administered orally In total, participants will complete three dosing visits (one per experimental period), each spaced 25 days apart. The study will evaluate the pharmacokinetics (PK) of the formulations, which refers to how the body absorbs, distributes, metabolizes, and eliminates the drugs.
• Healthy male or female volunteers.
• Age range between 18 and 55 years old.
• Weight at least 50kg and have a body mass index (BMI) between 19 and 30 kg/m2 at screening.
• Willingness to comply with and complete all study procedures, including consuming the protocol specified high-fat, high-calorie meal in 30 minutes.
• In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations at screening and check-in, and from the physical examination at screening and symptom-directed physical examination at baseline, as assessed by the investigator or designee.
• Abstinence from consuming St John's wort, grapefruit (juice), alcohol or tobacco and nicotine products for at least 72 hours prior to dosing and throughout treatment period.
• Abstinence from caffeine for the duration of the in-clinic confinement period, including all dosing days. Caffeinated beverages and products will not be available on site.
• Capable and willing to comply with protocol requirements during the study.
• Participant is willing and able to give informed consent for participation in the study.