ClinicalTrials.gg
RecruitingNCT07071532Updated Sep 16, 2026

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

A Phase 1 interventional study of ABBV-932 and Itraconazole in Bipolar Disorder, sponsored by AbbVie. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bipolar Disorder

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Keywords

  • Bipolar Disorder
  • ABBV-932
  • Itraconazole
03

In context

Bipolar Disorder

1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.

This study's planned enrollment of 20 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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
  • Participants with , 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

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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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.

    Drug: ABBV-932 · Drug: Itraconazole

Interventions

06

What researchers measure

Primary outcomes

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

    Cmax of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

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

    Tmax of ABBV-932 and active metabolites DCAR and DDCAR

    Time frame: Up to approximately 29 days

  3. 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

    Time frame: Up to approximately 29 days

  4. 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

    Time frame: Up to approximately 29 days

  5. 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

    Time frame: Up to approximately 29 days

  6. 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

    Time frame: Up to approximately 29 days

  7. 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

    Time frame: Up to approximately 29 days

  8. 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.

    Time frame: Up to approximately 61 days

07

Study locations

1 of 2 sites recruiting
  • CenExel Collaborative Neuroscience Research /ID# 282784
    Los Alamitos, California 90720, United States
    Recruiting
  • Acpru /Id# 276951
    Grayslake, Illinois 60030, United States
    Completed

    Not enrolling at this site.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07071532
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Aug 20, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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