Pharmacokinetics of R-BI 1015550 after single oral doses of BI 1015550 in Japanese healthy male subjects (open-label, nonrandomised, and parallel group design)

Nippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月18日

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•Healthy male subjects, age of 18 to 45 years (inclusive), body mass index (BMI)
•of 18.5 to 25.0 kg/m2 (inclusive)

•Any finding in the medical examination (including BP, PR, RR 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 140 mmHg,
•diastolic blood pressure outside the range of 40 to 90 mmHg, or PR outside the range of
•40 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 documented active or suspected malignancy or history of malignancy within 5 years
•prior to screening, except appropriately treated basal cell carcinoma or in situ squamous
•cell carcinoma of the skin or in situ carcinoma of uterine cervix
•Inability to comply with the dietary regimen of the trial site
•A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly
•greater than 450 ms in male) or any other relevant ECG finding at screening.
•A history of additional risk factors for Torsade de Pointes (such as heart failure,
•hypokalaemia, or family history of Long QT Syndrome)
•Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt, aborted
•attempt, or preparatory acts or behavior)
•History of vasculitis

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