A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder

Exclusion Criteria

• •Has a severe or profound intellectual disability (ie, IQ or GAI ≤ 45)
• •Participant is unable to self-report AEs, as determined by the investigator
• •Has a current diagnosis of psychosis spectrum disorders (bipolar disorder with psychotic features, schizo-affective disorder, delusional disorder, or schizophrenia)
• •Has a current diagnosis of major depression (participants with depression in remission for at least 12 months may be included)
• •Has an established history of psychotic spectrum disorders, early signs of psychosis at screening or Visit 2, or first degree relative with a lifetime diagnosis of psychosis spectrum disorders
• •Has had a seizure within the past 2 years
• •Has had changes in anticonvulsive therapy within the last 12 weeks
• •Has experienced myocardial infarction or clinically significant cardiac dysfunction within the 12 months prior to Visit 1 or has a history of clinically significant arterial vascular disease, including cerebrovascular and cardiovascular disease
• •Has supine systolic blood pressure \< 90 mmHg or \> 150 mmHg or supine diastolic blood pressure \< 50 mmHg or \> 105 mmHg or a postural drop in systolic blood pressure ≥ 20 mmHg or diastolic blood pressure ≥ 10 mmHg, with or without symptoms, at screening or baseline (prior to randomization)
• •Has a QTcF interval \> 450 ms or a history of additional risk factors for Torsades de pointes
• •Has any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study
• •Had in the 2 weeks prior to screening or up to randomization any condition that might affect baseline assessments
• •Has received administration of strong inducers of CYP3A4 ≤ 14 days prior to first doses of study intervention or have ongoing requirements for these medications
• •Is currently using or has used within the 12 weeks prior to screening recreational or medicinal cannabis, cannabinoid-based medications (botanical or synthetic; eg, Sativex, Epidiolex/Epidyolex, Nabilone, Dronabinol) and/or is unwilling to abstain for the duration of the study
• •Is currently taking bupropion
• •Has received another investigational product within the 12 weeks prior to the Screening Visit
• •Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention
• •Has been previously randomized into this study
• •Has impaired liver function at screening, as reflected by serum alanine aminotransferase or aspartate aminotransferase \> 1.5 × ULN, or total bilirubin \> ULN
• •Female participant who is pregnant (positive pregnancy test), lactating, or planning pregnancy during the study or within 3 months thereafter
• •Has any history of suicidal behavior or any suicidal ideation (with intent per C-SSRS questions 4 and 5) in the last month at screening (last month) or Visit 2 (randomization)
• •Has any known or suspected history of alcohol or substance abuse
• •Has positive drug abuse test at screening
• •Is living in the same household as another active participant of this study or nominated study partner is actively serving as a study partner for another participant of this study (Note: Same household does not apply to professional care-home environment)