Recruiting
Phase 1

ABBV-932 & Itraconazole

Sponsor:

AbbVie

Code:

NCT07071532

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ABBV-932

Itraconazole

Study Details

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

Study ID

NCT07071532

Start date

Aug 20, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: ABBV-932 with Itraconazole

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

Interventions

ABBV-932

Oral Capsule

Itraconazole

Oral Capsule

Primary outcome measure

  • Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR [ Time Frame: Up to approximately 29 days ]
  • Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR [ Time Frame: 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 [ Time Frame: Up to approximately 29 days ]
  • Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR [ Time Frame: Up to approximately 29 days ]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 and active metabolites DCAR and DDCAR [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to approximately 29 days ]
  • Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 61 days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

CenExel Collaborative Neuroscience Research /ID# 282784

Recruiting

Los Alamitos, California, United States, 90720

More Information

Sponsor

AbbVie

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • Bipolar Disorder
  • ABBV-932
  • Itraconazole

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-16.