Bipolar Disorder
Conditions
Keywords
Bipolar Disorder, ABBV-932, Itraconazole
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.
Interventions
DRUGABBV-932
Oral Capsule
DRUGItraconazole
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR | 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 | 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 | 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 | 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 | 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 | 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 | Up to approximately 29 days | AUCinf of ABBV-932 and active metabolites DCAR and DDCAR |
| Number of Participants Experiencing Adverse Events | 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. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed