Study of ZYN001 (transdermal patch) in Healthy Volunteers

Exclusion Criteria20

• Females who are pregnant, breast feeding 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 28 days after the last dose of study medication.
• Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, intrauterine device.
• Use of tobacco/nicotine-containing products within 4 weeks of the Screening Visit or during the study.
• Use of any prescription drugs (except hormonal contraception), vitamins, or herbal supplements within 4 weeks prior to the Screening Visit or any OTC drugs/vitamins within 72 hours prior to the first dose of study medication, except those approved in advance by the study physician.
• Use of cannabis or any THC containing product cannabidiol, a synthetic cannabinoid analogue (e.g., nabilone), or a synthetic endocannabinoid receptor agonist (e.g., Spice, K2), 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 urine drug screen, including, cocaine, THC, barbiturates, amphetamines, methamphetamines, methylenedioxymethamphetamine, oxycodone, methadone, benzodiazepines, and opiates or positive breathalyzer test for ethanol.
• 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 patch application, application site assessments, or affect absorption of the study drug.
• Use of cosmetics or lotions on the upper arms during the study.
• History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN001 or its excipients.
• Subject has taken caffeine, xanthine, or grapefruit products within 24 hours of dosing. Carbonated beverages will be prohibited during confinement at the research facility.
• History of treatment for, or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of two units of alcohol per day. Subjects are not allowed alcohol from 48 hours before the first dose of study treatment until the End of Study.
• 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.
• Subject has suspected or confirmed cardiovascular disease.
• Participation in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in an investigational device or another investigational drug study, during the course of this study.
• Patient has a history of actual suicide attempt in the last 5 years or more than one lifetime suicide attempt.
• Patient responded “yes” to Question 4 or 5 of neurological questionnaire during Screening.
• Current or past diagnosis of primary psychotic disorder, or positive family history (first degree relative) of psychotic disorder.
• Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.