A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Adult Subjects With Bipolar Disorder

AbbVie2 sites in 1 country20 target enrollmentStarted: August 20, 2026Last updated: September 16, 2026

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Recruiting
Sponsor
Enrollment: 20
Locations: 2
Primary Endpoint: Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Basic Science
Masking: None

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.

Arms & Interventions

ABBV-932 with Itraconazole

Experimental

Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.

Intervention: ABBV-932 (Drug)

ABBV-932 with Itraconazole

Experimental

Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.

Intervention: Itraconazole (Drug)