Pharmacokinetics, Safety and Tolerability of BI 1015550 Following Oral Administration in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of R-BI 1015550 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 aged 18 years and older. People without liver problems and people who have mild or moderate liver problems can join the study.
The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the blood of people with and without liver problems. Liver problems may change how a medicine is processed in the body.
Participants are in the study for about 2 weeks. During this time, they visit the study site 6 times. On the second visit, participants stay overnight at the study site for 4 nights. At the visits, doctors take blood samples to measure the levels of BI 1015550 in participants' blood. Then they compare the results between the groups of participants with and without liver problems. The doctors also check participants' health and take note of any unwanted effects.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 1015550 mild hepatic impairment
Participants with mild hepatic impairment, classified as Child-Pugh A (score 5 to 6 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours.
干预措施: BI 1015550 (Drug)
BI 1015550 moderate hepatic impairment
Participants with moderate hepatic impairment, classified as Child-Pugh B (score 7 to 9 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours.
干预措施: BI 1015550 (Drug)
BI 1015550 normal hepatic function
Participants with normal hepatic function administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours.
Participants with normal hepatic function were individually matched to participants with mild and/or moderate hepatic impairment. The matching criteria were age (± 10 years), sex and weight (± 15%). One participant with normal hepatic function could match one participant in one or both groups of participants with hepatic impairment.
干预措施: BI 1015550 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration.
Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups.
Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax)
时间窗: Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration.
Maximum measured concentration of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups.
次要结局
- Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration.)