Safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of BI 1291583 in healthy male Japanese subjects (double-blind, randomised, placebo-controlled, parallel group design)

Nippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 36 人开始时间: 2022年3月8日最近更新: 2024年8月19日

试验速览

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•Healthy male subjects, age of 20 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 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 50 to 90 mmHg, or pulse rate 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 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
•Chronic or relevant acute infections (including positive result of either Hepatitis A antibodies, Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B core antibody, Hepatitis C antibodies, HIV antigen and antibody, T-SPOT or Syphilis test at Screening)

the percentage [%] of subjects with drug-related AEs per treatment group

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发起方