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

Starting soon · Phase 1

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT07071532

Run by

AbbVie

People needed

20

Starts

2026-08-21

Expected to finish

2027-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Acpru /Id# 276951 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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