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NCT Number: NCT07071532

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel Collaborative Neuroscience Research /ID# 282784, Los Alamitos, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-932

Drug

Oral Capsule

Itraconazole

Drug

Oral Capsule

Other names: ITZ

Primary outcomes

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

    Time frame: Up to approximately 29 days

    Cmax of ABBV-932 and active metabolites DCAR and DDCAR

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

    Time frame: Up to approximately 29 days

    Tmax of ABBV-932 and active metabolites DCAR and DDCAR

  3. 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

    Ctrough of ABBV-932 and active metabolites DCAR and DDCAR

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

    Time frame: Up to approximately 29 days

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

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

    Time frame: Up to approximately 29 days

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

  6. 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

    AUCt of ABBV-932 and active metabolites DCAR and DDCAR

  7. 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

    AUCinf of ABBV-932 and active metabolites DCAR and DDCAR

  8. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 61 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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