An Open-label, Single Dose, Oral Administration, Sequential Two Parts Study to Compare the Pharmacokinetics of SCH 420814 / MK-3814 in Subjects With Mild and Moderate Chronic Hepatic Impairment With Their Respectively Matching Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. Part 2 compares healthy volunteers with participants with moderate hepatic impairment. Healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval [0.50, 2.00].
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 70 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
Mild Hepatic Impaired (HI) Part 1
Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
干预措施: Preladenant (Drug)
Healthy to Match Mild HI Part 1
Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
干预措施: Preladenant (Drug)
Moderate HI Part 2
Participants with moderate chronic liver disease enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
干预措施: Preladenant (Drug)
Healthy to Match Moderate HI Part 2
Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
干预措施: Preladenant (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant
时间窗: Pre-dose up to 72 hours postdose
For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.
Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant
时间窗: Pre-dose up to 72 hours postdose
For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.
次要结局
- AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant(Pre-dose up to 72 hours postdose)
- Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant(Pre-dose up to 72 hours postdose)
- AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant(Pre-dose up to 72 hours postdose)
- Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant(Pre-dose up to 72 hours postdose)
- AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant(Pre-dose up to 72 hours postdose)
- Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant(Pre-dose up to 72 hours postdose)