A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women

Официальное название

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male and Female Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Обзор

Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses. Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.

Вмешательства

• Препарат BI 3031185
  BI 3031185
• Препарат Midazolam
  Midazolam
• Препарат Placebo
  Placebo matching BI 3031185

Первичные конечные точки

• Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator [Срок оценки: Up to Day 54]

Вторичные конечные точки (2)

• Area under the concentration-time curve of BI 3031185 in plasma at steady state over a uniform dosing interval τ ((AUC) τ,ss ) [Срок оценки: Up to Day 42]
• Maximum measured concentration of BI 3031185 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [Срок оценки: Up to Day 42]

Критерии участия

Критерии включения

• Part A: Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests Part B: Healthy male and female (women of non-childbearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Part A: Age of 18 to 50 years (inclusive) Part B: Age of 18 to 55 years (inclusive)
• Part A: Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Part B: For female trial participants: Female trial participants who meet any of the following criteria (women of non-childbearing potential):

• Permanently sterilised (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
• Postmenopausal, defined as no menses for at least 1 year without an alternative medical cause. In questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L at screening is confirmatory
• Further inclusion criteria apply

Критерии исключения

• Any finding in the medical examination (including BP, Pulse rate (PR) or 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 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• 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

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Charité Research Organisation GmbH — Berlin

Идентификаторы

NCT: NCT06916702 · 1516-0002 · 2024-516921-29-00 · U1111-1311-3555

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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