RecruitingPhase 1
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
AbbVie · NCT07071532
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Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- August 20, 2026
- Record last updated
- September 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ABBV-932; Itraconazole
Conditions: Bipolar Disorder
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
CenExel Collaborative Neuroscience Research /ID# 282784
Los Alamitos, CA 90720
Study contacts (from the official record)
- ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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