NCT07071532RecruitingPhase 1
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 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Adult Subjects With Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 20 Aug 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- AbbVie
- Diseases
- Bipolar disorder
- NCT number
- NCT07071532
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 20 Aug 2026 to the primary completion date, Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Acpru /Id# 276951 Coordinator of this site? Confirm its status | Grayslake | United States | Completed |
| CenExel Collaborative Neuroscience Research /ID# 282784 Coordinator of this site? Confirm its status | Los Alamitos | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.