An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Mild and Moderate Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of MK-8527
研究概览
简要总结
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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:
- •All participants:
- •Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing
- •Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m^2
- •Participants with Mild HI (Group 1) and Moderate HI (Group 2):
- •Has mild or moderate hepatic impairment
- •Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
- •Is generally in good health with the exception of HI
- •Healthy Control Participants (Group 3):
- •- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •All participants:
- •Has a history of cancer (malignancy)
- •Has positive results for human immunodeficiency virus (HIV)
- •Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
- •Participants with Mild HI (Group 1) and Moderate HI (Group 2):
- •With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease
- •Is positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb)
- •Is positive for Hepatitis C Virus (HCV)
研究组 & 干预措施
Mild Hepatic Impairment (Group 1)
All participants will receive a single dose of MK-8527 on Day 1.
干预措施: MK-8527 (Drug)
Moderate Hepatic Impairment (Group 2)
All participants will receive a single dose of MK-8527 on Day 1.
干预措施: MK-8527 (Drug)
Healthy (Group 3)
All participants will receive a single dose of MK-8527 on Day 1.
干预措施: MK-8527 (Drug)
结局指标
主要结局
Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of MK-8527
时间窗: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527.
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-8527
时间窗: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-8527.
Maximum Observed Concentration (Cmax) of MK-8527
时间窗: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Cmax of MK-8527.
Time to Maximum Concentration (Tmax) of MK-8527
时间窗: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Tmax of MK-8527.
Apparent Terminal Half-life (t1/2) of MK-8527
时间窗: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527.
Apparent Clearance (CL/F) of MK-8527
时间窗: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
时间窗: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527.
次要结局
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to approximately 29 days)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 29 days)
- AUC0-inf of MK-8527-triphosphate (TP) in peripheral blood mononuclear cell (PBMCs)(Predose and at designated timepoints up to 672 hours post dose)
- Area under the concentration versus time curve from 0 to 672 hours after dosing (AUC0-672hrs) of MK-8527-TP in PBMCs(At designated timepoints pre dose and up to approximately 672 hours post dose)
- Cmax of MK-8527-TP in PBMCs(Predose and at designated timepoints up to 672 hours post dose)
- Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs(Predose and at designated timepoints up to 672 hours post dose)
- Tmax of MK-8527-TP in PBMCs(Predose and at designated timepoints up to 672 hours post dose)
- T1/2 of MK-8527-TP in PBMCs(Predose and at designated timepoints up to 672 hours post dose)