[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598441":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":21,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":21,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":21,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":73,"whyStopped":21,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ABBV-932 with Itraconazole","EXPERIMENTAL","Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.",[13,14],"Drug: ABBV-932","Drug: Itraconazole",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","ABBV-932","Oral Capsule",[9],null,{"type":17,"name":23,"description":19,"armGroupLabels":24,"otherNames":25},"Itraconazole",[9],[26],"ITZ",[28],{"name":29,"affiliation":5,"role":30},"ABBVIE INC.","STUDY_DIRECTOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[38],{"facility":39,"status":21,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":21},"Acpru \u002FId# 276951","Grayslake","Illinois","60030","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-88.04175,42.34447,{"lat":49,"lon":48},{"type":52,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100598441","phase-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-100598441",false,"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","A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Adult Subjects With Bipolar Disorder","Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 18.0 to ≤ 38.0 kg\u002Fm\\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* 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\n* 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).\n\nExclusion Criteria:\n\n* Participants with bipolar I or II disorder subject psychiatric history:\n\n  * Clinical Global Impression-Severity (CGI-S) \\> 4 at Screening or Baseline.\n  * History of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.\n  * Major depressive or manic episode within the past 3 months prior to screening.\n  * Lifetime history of schizophrenia spectrum or other psychotic disorders, dissociative disorders, or neurocognitive disorders.\n  * History of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.\n* 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\u002For 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.\n* 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\u002Fday lorazepam.","ALL","18 Years","65 Years",{"count":64,"type":65},20,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","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.",[71],"Bipolar Disorder",[71,18,23],"NOT_YET_RECRUITING","2026-08-04",{"date":76,"type":77},"2026-08-06","ACTUAL",{"date":79,"type":65},"2026-08-21",{"date":81,"type":65},"2027-02",{"name":5,"class":6},1]