Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome

Exclusion Criteria

• •Known use of cannabis or cannabinoid-containing products for 4 weeks prior to baseline.
• •History of chronic liver diseases, such as cirrhosis or chronic hepatitis due to any cause, or suspected alcohol abuse.
• •Use of weight loss agents or drugs known to affect appetite (including glucagon-like peptide-1 \[GLP-1\] analogs) within 2 months prior to screening.
• •Uncontrolled Type I and Type II diabetes.
• •Currently taking concomitant medication that are strong-moderate inhibitors/inducers/sensitive substrates with a narrow therapeutic index for CYP2C19 or CYP3A.
• •Co-morbid condition or disease (such as respiratory disease, heart disease, or psychiatric disorder) diagnosed less than 1 month prior to screening.
• •History or presence of gastrointestinal or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs as determined by the Investigator.
• •Participants who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.
• •Clinically significant abnormalities on electrocardiogram at screening or other evidence of heart disease as determined by the Investigator.
• •Has screening systolic blood pressure ≥160 millimeters of mercury (mmHg) and diastolic blood pressure \>100 mm Hg (may be repeated 1 additional time after 5 minutes rest to verify). Participants with hypertensive levels lower than those specified may be excluded at the Investigator's discretion if deemed to be in the best interest of the participant.
• •Currently taking felbamate.
• •Uncontrolled sleep apnea.
• •Pregnant or lactating female.
• •History of hypersensitivity to drugs with a similar chemical structure or class as cannabidiol.
• •Unwillingness or inability to follow the procedures outlined in the protocol.
• •Participant judged by the investigator or sponsor (or designee) as unable to comply with the treatment protocol, including appropriate supportive care, follow-up and research tests.
• •Positive drug screen, including tetrahydrocannabinol, at time of screening.
• •Creatinine clearance test of \< 30 milliliters/minute (mL/min).