Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 3031185 in Japanese healthy male trial participants (single-blind, randomised, placebocontrolled, 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) (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)

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试验速览

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•SD and 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 (BP, PR), 12-lead ECG, and clinical laboratory tests
•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
•Surgically sterilised (including hysterectomy, bilateral salpingectomy, and bilateral
•oophorectomy)
•SD and MD part:
•Age of 18 to 45 years (inclusive)
•Age of 18 to 64 years (inclusive)
•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

•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
•Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

发起方

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