A Study in Japanese Healthy Men to Test How Well Different Doses of BI 3031185 Are Tolerated and a Study in Japanese Healthy Women to Test Whether BI 3031185 Influences the Amount of a Contraceptive in the Blood

Официальное название

Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of BI 3031185 in Japanese Healthy Male Trial Participants (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Multiple Doses of BI 3031185 on Pharmacokinetics of a Single Dose of a Combination of Drospirenone and Ethinylestradiol (Oral Contraceptive) in Japanese Healthy Female Trial Participants (Non-randomised, Open-label, Fixed Sequence Design)

Обзор

Single dose (SD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of single dose. Multiple doses (MD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of multiple doses. Oral contraceptives (OC) part: The main objective of this trial is to investigate the effect of multiple oral doses of BI 3031185 on pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) (YAZ®) in Japanese healthy female trial participants.

Вмешательства

• Препарат BI 3031185
  BI 3031185
• Препарат Placebo matching BI 3031185
  Placebo matching BI 3031185
• Препарат Midazolam
  Midazolam
• Препарат YAZ®
  YAZ®

Первичные конечные точки

• SD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator [Срок оценки: Up to 29 days]
• MD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator [Срок оценки: Up to 47 days]
• OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [Срок оценки: Up to 29 days]
• OC part: Maximum measured concentration of the analyte in plasma (Cmax) [Срок оценки: Up to 29 days]

Вторичные конечные точки (5)

• SD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [Срок оценки: Up to 11 days]
• SD part: Maximum measured concentration of the analyte in plasma (Cmax) [Срок оценки: Up to 11 days]
• MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) [Срок оценки: Up to 39 days]
• MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [Срок оценки: Up to 39 days]
• OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [Срок оценки: Up to 29 days]

Критерии участия

Критерии включения

• Single dose (SD) and multiple doses (MD) part: Healthy male trial participant 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 Oral contraceptives (OC) part: Women of non-childbearing potential (WONCBP) who meet postmenopausal or surgically sterilised 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

• Postmenopausal, defined as no menses for 1 year without an alternative medical cause.
• Surgically sterilised (including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
• SD and MD part: Age of 18 to 45 years (inclusive) OC part: Age of 18 to 64 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (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 BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 40 to 89 mmHg, or pulse rate outside the range of 45 to 99 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

Простое слепое

Основная цель

Лечение

Центры проведения

Япония · 1 центр

• Fukuoka Mirai Hospital — Fukuoka, Fukuoka

Идентификаторы

NCT: NCT07656792 · 1516-0005 · U1111-1331-6622

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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