A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder

Korábbi kezelés

• Participants with bipolar I or II disorder subject psychiatric history:
  • Clinical Global Impression-Severity (CGI-S) > 4 at Screening or Baseline.
  • History of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
  • Major depressive or manic episode within the past 3 months prior to screening.
  • Lifetime history of schizophrenia spectrum or other psychotic disorders, dissociative disorders, or neurocognitive disorders.
  • History of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
• History of suicidal ideation within 1 year prior to study treatment administration as evidenced by answering "yes" to any question on the suicidal ideation portion of Columbia Suicide Severity Rating Scale (C-SSRS) at screening and/or history of suicidal behavior within 2 years prior to study treatment administration as evidenced by any "yes" answer to suicidal behavior questions on the C-SSRS.
• History with any protocol prohibited medications, supplements, or herbal products, including any psychotropic drug or any drug with psychotropic activity (e.g., antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential) within 14 days or 5 half-lives of the medication (whichever is longer), prior to study treatment administration, with the exception of protocol-allowed medications listed in the protocol, including a total daily dose of ≤ 2 mg/day lorazepam.

• Body Mass Index (BMI) ≥ 18.0 to ≤ 38.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
• Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0.2).