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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

RecruitingPhase 1Ages 18 Years - 65 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in adult participants with bipolar disorder.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Body Mass Index (BMI) โ‰ฅ 18.0 to โ‰ค 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). Exclusion Criteria: * 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 โ‰ค 2 mg/day lorazepam.
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What it tests

  • ABBV-932
  • Itraconazole
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Where

2 sites
CenExel Collaborative Neuroscience Research /ID# 282784
Los Alamitos, United States
Acpru /Id# 276951
Grayslake, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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