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

Официальное название

A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of ABBV-932 in Adult Subjects With Bipolar Disorder

Обзор

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.

Вмешательства

• Препарат ABBV-932
  Oral Capsule
• Препарат Itraconazole
  Oral Capsule

Первичные конечные точки

• Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR [Срок оценки: Up to approximately 29 days]
• Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR [Срок оценки: Up to approximately 29 days]
• Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR [Срок оценки: Up to approximately 29 days]
• Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR [Срок оценки: Up to approximately 29 days]
• Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 and active metabolites DCAR and DDCAR [Срок оценки: Up to approximately 29 days]
• Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 and active metabolites DCAR and DDCAR [Срок оценки: Up to approximately 29 days]
• Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 and active metabolites DCAR and DDCAR [Срок оценки: Up to approximately 29 days]
• Number of Participants Experiencing Adverse Events [Срок оценки: Up to approximately 61 days]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Acpru /Id# 276951 — Grayslake

Идентификаторы

NCT: NCT07071532 · M24-966

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗