A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated

Официальное название

A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants

Обзор

The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.

Вмешательства

• Препарат BI 3776528
  BI 3776528
• Препарат Placebo matching BI 3776528
  Placebo matching BI 3776528
• Препарат short-acting benzodiazepine
  short-acting benzodiazepine

Первичные конечные точки

• Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator [Срок оценки: up to 62 days]
• Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [Срок оценки: up to 27 days]
• Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma) [Срок оценки: up to 27 days]

Вторичные конечные точки (6)

• Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Срок оценки: up to 27 days]
• Part 1a: Cmax of BI 3776528 in plasma [Срок оценки: up to 27 days]
• Part 1b: AUC0-∞ of BI 3776528 in plasma [Срок оценки: up to 27 days]
• Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [Срок оценки: up to 27 days]
• Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [Срок оценки: up to 27 days]
• Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [Срок оценки: up to 27 days]

Критерии участия

Критерии включения

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory.
• Age of 18 to 50 years (inclusive)
• BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Критерии исключения

• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
• Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further 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

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Charité Research Organisation GmbH — Berlin

Идентификаторы

NCT: NCT06745297 · 1526-0001 · 2024-515222-92-00 · U1111-1307-8288

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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