Study of ZYN002 (cannabidiol gel) in 40 Healthy Volunteers

Exclusion Criteria22

• Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential, and male subjects with a partner of childbearing potential, who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 30 days after the last dose of study medication.
• a. Standard acceptable methods include: males to use a condom, female participants and female partners of male participants who are women of child bearing potential to use an actual highly effective method of contraception (i.e. hormonal method with a <1% annual failure rate or an IUD), abstinence, and vasectomy.
• Has eaten any food or drink/beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussel sprouts, or mustard), and charbroiled meats within one week prior to study start through the end of the study.
• Use of tobacco/nicotine-containing products within one month of Screening Visit or during the study.
• Use of any prescription drugs, except hormonal contraception, or herbal supplements within four weeks prior to Screening or any over-the-counter (OTC) drugs/vitamins within 72 hours prior to first dose of study medication through the End of Study Visit.
• Use of cannabis or any CBD-containing product within four weeks of the Screening Visit or during the study.
• Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies.
• Positive drug screen for ethanol, cocaine, delta-9-tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines, and opiates at Screening and Day -1.
• Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the investigator, preclude study participation or interfere with the evaluation of the study treatment.
• Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
• Use of cosmetics (excluding study moisturizer) on the shoulder/upper arms or upper thighs, during the study period.
• History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN002 or its excipients.
• History of treatment for, or evidence of alcohol or drug abuse within the past year or current alcohol consumption exceeding an average of two units of alcohol per day.
• History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements.
• Has suspected or confirmed cardiovascular disease.
• Participation in any investigational product or device study within 30 days prior to Screening Visit, or is scheduled to participate in an investigational device or another investigational drug study during the course of this study.
• Subject responded “yes” to Question 4 or 5 of C-SSRS during Screening and Day-1.
• Demonstrates behaviour indicating unreliability or inability to comply with the requirements of the protocol.
• Subject has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds).
• A history of additional risk factors for Torsades de pointes, (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• The use of concomitant medications that prolong the QT/QTc interval.
• Subjects with ALT/AST >3 times the upper limit of normal.