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

NCT07071532 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: M24-966
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; ABBV-932; Itraconazole

Outcome Measures

Primary Outcomes (8)

• Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR

  Cmax of ABBV-932 and active metabolites DCAR and DDCAR

  Up to approximately 29 days

• Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR

  Tmax of ABBV-932 and active metabolites DCAR and DDCAR

  Up to approximately 29 days

• Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR

  Ctrough of ABBV-932 and active metabolites DCAR and DDCAR

  Up to approximately 29 days

• Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR

  (β) of ABBV-932 and active metabolites DCAR and DDCAR

  Up to approximately 29 days

• Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 and active metabolites DCAR and DDCAR

  Terminal phase elimination half-life of ABBV-932 and active metabolites DCAR and DDCAR

  Up to approximately 29 days

• Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 and active metabolites DCAR and DDCAR

  AUCt of ABBV-932 and active metabolites DCAR and DDCAR

  Up to approximately 29 days

• Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 and active metabolites DCAR and DDCAR

  AUCinf of ABBV-932 and active metabolites DCAR and DDCAR

  Up to approximately 29 days

• Number of Participants Experiencing Adverse Events

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 61 days

Study Arms (1)

ABBV-932 with Itraconazole

EXPERIMENTAL

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

Drug: ABBV-932; Drug: Itraconazole

Interventions

ABBV-932 DRUG

Oral Capsule

ABBV-932 with Itraconazole

Itraconazole DRUG

Oral Capsule

Also known as: ITZ

ABBV-932 with Itraconazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 276951

Grayslake, Illinois, 60030, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start (Estimated): August 21, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)