An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening.

Primary diagnosis is not bipolar I disorder.

History of clozapine treatment for treatment-resistant psychosis.

History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening.