A Study to Evaluate the Blood Levels, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

Официальное название

A Phase 1, Double-Blinded, Randomized, Placebo-Controlled, Two Parallel Cohort Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants

Обзор

The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants

Вмешательства

• Препарат BMS-986368
  Specified dose on specified days
• Другое BMS-986368-matching Placebo
  Specified dose of specified days

Первичные конечные точки

• Maximum observed concentration (Cmax) [Срок оценки: Up to approximately Day 17]
• Time of maximum observed concentration (Tmax) [Срок оценки: Up to approximately Day 17]
• Area under the concentration-time curve (AUC) [Срок оценки: Up to approximately Day 17]

Вторичные конечные точки (7)

• Number of participants with adverse events (AEs) [Срок оценки: Up to approximately Day 44]
• Number of participants with serious adverse events (SAEs) [Срок оценки: Up to approximately Day 44]
• Number of participants with clinically significant vital sign measurements [Срок оценки: Up to approximately Day 17]
• Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations [Срок оценки: Up to approximately Day 17]
• Number of participants with clinically significant laboratory assessments [Срок оценки: Up to approximately Day 17]
• Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to approximately Day 17]
• Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI) [Срок оценки: Up to approximately Day 17]

Критерии участия

Критерии включения

• Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).
• Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).
• Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.

Критерии исключения

• Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.
• Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
• Other protocol-defined Inclusion/Exclusion criteria apply.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07700329 · IM045-1027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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