Safety, tolerability, and pharmacokinetics of single rising oral dose and multiple rising oral doses of BI 706321 in healthy Japanese male subjects and single oral dose of BI 706321 in healthy Chinese male subjects (double-blind, randomised, placebo-controlled, parallel group design)

Nippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年11月4日

试验速览

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•Healthy male subjects according to the assessment of the investigator, as based on a
•complete medical history including a medical examination, vital signs (BP, PR), 12-lead
•ECG, and clinical laboratory tests
•Japanese (Part I) or Chinese (Part II)ethnicity
•BMI of 18.5 to 25.0 kg/m2 (inclusive)
•Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

•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 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate 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
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
•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 stroke), and other relevant neurological or psychiatric disorders

The percentage of subjects with drug-related adverse events

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发起方