Pharmacokinetics, Safety and Tolerability of BI 1584862 in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Class A, B, and C) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomized, Single-dose, Parallel, Individual-matched Design Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
研究概览
简要总结
This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part. This study includes people with mild, moderate, and severe liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild, moderate, and severe liver problems affect how the body handles a medicine called BI 1584862.
Participants take BI 1584862 once. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and to make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study.
Participants are in the study for about 5 weeks. During this time, they visit the study site 3 times. This also includes an overnight stay for 4 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the site staff regularly takes blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria applicable to all participants
- •Male or female participants
- •Age of 18 to 80 years (inclusive)
- •Body mass index (BMI) of 18.0 to 42 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Men participants must be willing and able to use contraception (condom, abstinence) from time point of administration of trial medication until 3 days after drug administration to prevent pregnancy and/or exposure of an existing embryo or fetus to the investigational product. Female partners do not need to use contraception
- •Women of childbearing potential are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 30 days after administration of trial medication. The following methods of contraception are considered adequate for female participants of childbearing potential:
- •Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
- •Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- •Sexually abstinent (true abstinence, in line with the preferred and usual lifestyle of the subject)
- •A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant.
- •Female participants are not considered to be of childbearing potential if they are either surgically sterilised (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L and oestradiol below 30 ng/L is confirmatory).
- •Further inclusion criteria apply.
排除标准
- •Exclusion criteria for all participants
- •Any medical condition or finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) assessed as clinically relevant by the investigator (apart from any hepatic impairment and associated underlying diseases)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying disease)
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator (apart from underlying disease)
- •For diabetics only: uncontrolled diabetes mellitus with an Hemoglobin A1c (HbA1c) > 9
- •Severe gastrointestinal, renal (Estimated glomerular filtration rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <40 ml/min/1.73 m2 for the hepatic impaired patients and eGFR CKD-EPI <90 ml/min/1.73 m2 for matched controls), respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the Investigator.
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, repetitive fainting spells, or repetitive blackouts
- •Relevant chronic or acute infections Further exclusion criteria apply.
研究组 & 干预措施
Participants with moderate hepatic impairment (Child-Pugh B)
干预措施: BI 1584862 (Drug)
Participants with severe hepatic impairment (Child-Pugh C)
干预措施: BI 1584862 (Drug)
Participants with normal hepatic function
干预措施: BI 1584862 (Drug)
Participants with mild hepatic impairment (Child-Pugh A)
干预措施: BI 1584862 (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 4 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 4 days)