Safety, tolerability, and pharmacokinetics of single rising oral doses of BI 1584862 in Japanese healthy male subjects (single- masked, randomised, placebo-controlled, parallel group design)

Nippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年8月23日

试验速览

阶段: 不适用
状态: 已完成
发起方: Nippon Boehringer Ingelheim Co., Ltd.
入组人数: 32
主要终点: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator

暂无简介。

•Healthy male subjects, age of 18 to 45 years (inclusive), body mass index (BMI) of 18.5 to 24.9 kg/m2 (inclusive)

•Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit.
•Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 99 mmHg, or pulse rate outside the range of 40 to 99 bpm at screening visit.
•Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit.
•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

Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator

Percentage of subjects treated with investigational drug who experience such an event

未报告次要终点

发起方