Safety, tolerability, and pharmacokinetics of single rising intravenous doses of BI 765845 in healthy male Japanese subjects (single-blind, randomised, placebo-controlled, parallel group design)

Boehringer Ingelheim0 个研究点目标入组 32 人开始时间: 2023年7月27日最近更新: 2024年10月23日

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•Healthy male 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
•Japanese ethnicity
•Age of 18 to 45 years (inclusive)
•BMI of 18.5 to 24.9 kg/m2 (inclusive)
•Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (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 BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR 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
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (including any history of cardiovascular diseases such as atherosclerosis, previous myocardial infarction or angina pectoris)
•Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
•Diseases of the central nervous system (including but not limited to any kind of seizures or history of stroke), and other relevant neurological or psychiatric disorders

Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator.

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