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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 1
A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Adult Subjects With Bipolar Disorder
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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). 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 ≤ 2 mg/day lorazepam.
About the study
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.
What is being tested
- ABBV-932 (drug)
- Itraconazole (drug)
Sponsor: AbbVie · Participants: 20 · Started: Aug 20, 2026
Contact the study team
- ABBVIE CALL CENTER · Phone: 844-663-3742
Official record on ClinicalTrials.gov — NCT07071532
Locations in the U.S.
| California | CenExel Collaborative Neuroscience Research /ID# 282784, Los Alamitos |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.