NCT07071532 · AbbVie
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
What this study is about
This study will assess the side effects and how taken by mouth ABBV-932 moves through the body when given with taken by mouth Itraconazole in adult participants with bipolar disorder.
View original scientific description
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.
Interventions
DRUG
ABBV-932
Oral Capsule
DRUG
Itraconazole
Oral Capsule
Primary outcome measures
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
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
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
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
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
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
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Alamitos, California
- Grayslake, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2026 · Source of record for eligibility and locations