A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants

Официальное название

A Phase 1, Double-blind, Placebo-controlled, First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ABBV-1042 in Healthy Subjects

Обзор

This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.

Вмешательства

• Препарат ABBV-1042
  Oral Solution
• Препарат Placebo
  Oral Solution

Первичные конечные точки

• Number of Participants Experiencing Adverse Events [Срок оценки: Up to approximately 32 days]
• Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [Срок оценки: Up to approximately 3 days]
• Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to approximately 3 days]
• Number of Participants with Abnormal Change in Physical Examinations [Срок оценки: Up to approximately 3 days]
• Number of Participants with Change from Baseline in Electrocardiogram (ECG) [Срок оценки: Up to approximately 3 days]
• Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [Срок оценки: Up to approximately 3 days]
• Maximum Plasma Concentration (Cmax) of ABBV-1042 [Срок оценки: Up to approximately 3 days]
• Time to Cmax (Tmax) of ABBV-1042 [Срок оценки: Up to approximately 3 days]
• Apparent terminal phase elimination constant (β) of ABBV-1042 [Срок оценки: Up to approximately 3 days]
• Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042 [Срок оценки: Up to approximately 3 days]

Критерии участия

Критерии включения

• BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight ˃ 45 kg at the time of screening and upon initial confinement.
• 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

Критерии исключения

• History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
• Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Acpru /Id# 279405 — Grayslake

Идентификаторы

NCT: NCT07222709 · M25-818

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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