A 2-part, Open-label, Single-dose Study to Investigate the Influence of Hepatic Impairment on the Pharmacokinetics of MK-8189
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of MK-8189
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of MK-8189 in participants with mild hepatic impairment to healthy participants.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent)
- •Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention
- •(For hepatically impaired participants) Has a diagnosis of chronic (>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment
排除标准
- •Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
- •Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies
- •Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food
- •Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit
- •Consumes greater than 3 glasses of alcoholic beverages per day
- •Consumes greater than 6 servings (1 serving is ~120 mg of caffeine) caffeinated beverages per day
- •(For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study
研究组 & 干预措施
Moderate Hepatic Impairment Participants
Participants with hepatic impairment will receive a single dose of MK-8189 4 mg orally on Day 1.
干预措施: MK-8189 (Drug)
Healthy Participants
Healthy participants will receive a single dose of MK-8189 4 mg orally on Day 1.
干预措施: MK-8189 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of MK-8189
时间窗: Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy); 60, 84, 108 and 120 hours post-dose (hepatic impairment)
Cmax is the maximum concentration of MK-8189 observed in plasma. Blood samples collected pre and post-dose at multiple timepoints were used to estimate Cmax following MK-8189 administration. Geometric least-squares mean and confidence intervals of Cmax were calculated using a linear fixed effects model performed on natural log-transformed values.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189
时间窗: Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy participants); 60, 84, 108 and 120 hours post-dose (hepatic impairment participants)
AUC0-inf is a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood samples collected pre and post-dose at multiple timepoints were used to estimate AUC0-inf following MK-8189 administration. Geometric least-squares mean and confidence intervals for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values.
次要结局
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to approximately 15 days)
- Number of Participants Who Discontinue From the Study Due to an AE(Up to approximately 15 days)