An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Moderate Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat
研究概览
简要总结
Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with 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 —（Adult, Older Adult）
- 性别
- Male
- 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 ≤ 42.0 kg/m2
- •Participants with moderate hepatic impairment:
- •Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
排除标准
- •include but are not limited to the following:
- •All participants:
- •Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
- •Has a history of cancer (malignancy)
- •Has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •Participants with moderate hepatic impairment
- •Has unstable electrolyte abnormalities or electrolyte abnormalities that are considered difficult to manage for participants with hepatic impairment
- •Has a history of liver or other solid organ transplantation
研究组 & 干预措施
Moderate Hepatic Impairment
On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2.
干预措施: Opevesostat (Drug)
Moderate Hepatic Impairment
On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2.
干预措施: Prednisone (Drug)
Moderate Hepatic Impairment
On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2.
干预措施: Fludrocortisone acetate (Drug)
Healthy
On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing.
干预措施: Opevesostat (Drug)
Healthy
On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing.
干预措施: Prednisone (Drug)
Healthy
On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing.
干预措施: Fludrocortisone acetate (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat
时间窗: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the AUC0-inf of opevesostat.
Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat
时间窗: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the AUC0-last of opevesostat.
Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat
时间窗: At designated timepoints (up to approximately 24 hours post-dose)
Plasma samples will be collected to determine the AUC0-24 of opevesostat.
Maximum Observed Concentration (Cmax) of Opevesestat
时间窗: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the Cmax of opevesostat.
Time to Maximum Concentration (Tmax) of Opevesestat
时间窗: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the Tmax of opevesostat.
Apparent Terminal Half-life (t1/2) of Opevesestat
时间窗: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the t1/2 of opevesostat.
Apparent Clearance (CL/F) of Opevesestat
时间窗: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the CL/F of opevesostat.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat
时间窗: At designated timepoints (up to approximately 96 hours post-dose)
Plasma samples will be collected to determine the Vz/F of opevesostat.
次要结局
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to approximately 2 weeks)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 2 weeks)