An Open-Label, Single-Dose Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MK-3543
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bomedemstat in Participants with Mild Hepatic Impairment (HI)
研究概览
简要总结
The purpose of this study is to learn what happens to bomedemstat (MK-3543) in a person's body over time. Researchers will compare what happens to bomedemstat in the body when it is given to participants with mild or moderate hepatic (liver) impairment and healthy participants.
Participants will be allocated to one of three groups: mild hepatic impairment (HI), moderate HI, or healthy matched control. All participants will receive a single oral dose of bomedemstat on Day 1.
Healthy control participants will be enrolled after hepatic impairment participants have been dosed. Healthy control participants will be matched for the mean age and mean body-mass index (BMI) of all participants with HI (mild and moderate HI combined) and sex to each HI group separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Is a non-smoker or is a moderate smoker for at least 3 months prior to dosing
- •Participants with Mild and Moderate HI
- •Is classified as having either mild HI (Group 1) or moderate HI (Group 2) score on the Child-Pugh scale ranging from 5 to 6 (mild) or 7 to 9 (moderate)
- •Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
- •Healthy Control Participants:
- •Must match the mean age (± 15 years) of participants with mild HI and moderate HI
- •Must match the mean body-mass index (BMI) (± 25%) of participants with mild HI (Group 1) and moderate HI
- •Must match the sex ratio (±2) of participants in each HI group, separately
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •All Participants
- •History of cancer (malignancy)
- •Female participants of childbearing potential
- •Is positive for Hepatitis C virus (HCV)
- •Is positive for Hepatitis B surface antigen (HBsAg)
- •Is positive for human immunodeficiency virus (HIV)
- •Participants with Mild and Moderate HI
- •Has any significant arrhythmia or conduction abnormality
- •Severe complications of liver disease within the preceding 3 months
- •Primary biliary cholangitis or biliary obstruction
- •Has a history of a recent variceal bleeds
- •Has evidence of hepatorenal syndrome
- •Has a history of liver or other solid organ transplantation
- •Has an active infection requiring systemic therapy
- •Requires paracentesis more often than 2 times per month
- •Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
- •Healthy Control Participants
- •Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Is a regular user of cannabis products within approximately 6 months of study
研究组 & 干预措施
Mild Hepatic Impairment
Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1.
干预措施: Bomedemstat (Drug)
Moderate Hepatic Impairment
Participants with mild hepatic impairment will receive a single oral 25 mg dose of bomedemstat on Day 1.
干预措施: Bomedemstat (Drug)
Healthy Matched Control
Healthy participants will receive a single oral 25 mg dose of bomedemstat on Day 1.
干预措施: Bomedemstat (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Bomedemstat in Participants with Mild Hepatic Impairment (HI)
时间窗: Up to 216 hours
Blood samples collected to determine the AUC0-inf of bomedemstat.
Maximum Plasma Concentration (Cmax) of Bomedemstat in Participants with Mild HI
时间窗: Up to 216 hours
Blood samples collected to determine the Cmax of bomedemstat.
AUC0-Inf of Bomedemstat in Participants with Moderate HI
时间窗: Up to 216 hours
Blood samples collected to determine the AUC0-inf of bomedemstat.
Cmax of Bomedemstat in Participants with Moderate HI
时间窗: Up to 216 hours
Blood samples collected to determine the Cmax of bomedemstat.
次要结局
- Time to Maximum Plasma Concentration (Tmax) of Bomedemstat in Participants with Mild HI(Up to 216 hours)
- Number of Participants Who Experience an Adverse Event (AE)(Up to 14 days)
- Number of Participants Who Discontinue Study Due to an AE(Up to 14 days)
- Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Bomedemstat in Participants with Mild HI(Up to 216 hours)
- Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Bomedemstat in Participants with Mild HI(At designated timepoints up to 24 hours postdose)
- Plasma Concentration at 24 Hours (C24) of Bomedemstat in Participants with Mild HI(At designated timepoints up to 24 hours postdose)
- Apparent Terminal Half-life (t1/2) of Bomedemstat in Participants with Mild HI(Up to 216 hours)
- Apparent Clearance (CL/F) of Bomedemstat in Participants with Mild HI(Up to 216 hours)
- AUC0-Last of Bomedemstat in Participants with Moderate HI(Up to 216 hours)
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of Bomedemstat in Participants with Mild HI(Up to 216 hours)
- Tmax of Bomedemstat in Participants with Moderate HI(Up to 216 hours)
- AUC0-24hrs of Bomedemstat in Participants with Moderate HI(At designated timepoints up to 24 hours postdose)
- C24 of Bomedemstat in Participants with Moderate HI(At designated timepoints up to 24 hours postdose)
- t1/2 of Bomedemstat in Participants with Moderate HI(Up to 216 hours)
- CL/F of Bomedemstat in Participants with Moderate HI(Up to 216 hours)
- Vz/F of Bomedemstat in Participants with Moderate HI(Up to 216 hours)