A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia

Exclusion Criteria

• •1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening)
• •2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results, to exclude patients with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the liver function test results.
• •3. History of or high risk of urinary retention, gastric retention, or narrow-angle glaucoma
• •4. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months
• •5. Has a DSM-5 diagnosis of moderate to severe substance abuse disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current abuse as determined by urine toxicology screen or alcohol test. A screening subject with mild substance abuse disorder within the 12 months before screening must be discussed and agreed upon with the medical monitor before he/she can be allowed into the study.
• •6. Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at screening
• •7. Pregnant, lactating, or less than 3 months postpartum. Sperm donation is not allowed for 90 days after the final dose of study drug
• •8. If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
• •9. Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening
• •10. Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or required clozapine within the last 12 months
• •11. Risk of violent or destructive behavior
• •12. Current involuntary hospitalization or incarceration
• •13. Participation in another clinical study in which the subject received an experimental or investigational drug agent within 3 months of screening