NCT02452801已完成1 期
A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS 5461 in Subjects With Hepatic Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
研究概览
简要总结
This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •For all subjects:
- •Has a body mass index (BMI) of 18.0-35.0 kg/m2 and a total body weight >50 kg
- •Agrees to use an approved method of contraception for the duration of the study
- •Additional criteria may apply
- •For subjects with hepatic impairment:
- •Has mild, moderate, or severe hepatic impairment
- •Has hepatic dysfunction due to hepatocellular disease
- •Additional criteria may apply
排除标准
- •For all subjects:
- •Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than hepatic impairment
- •Has a history of gastrointestinal surgery, excluding appendectomy or cholecystectomy
- •Is pregnant, planning to become pregnant, or lactating
- •Has a history of clinically significant allergy or a hypersensitivity to opioids
- •Additional criteria may apply
- •For subjects with hepatic impairment:
- •Has evidence of hepatocellular carcinoma, acute liver disease, biliary obstruction, severe ascites, severe portal hypertension, surgical systemic shunts, or other clinically relevant liver-related disorder or condition
- •Has received a liver transplant
- •Has had esophageal variceal bleeding in the past 2 months
- •Additional criteria may apply
研究组 & 干预措施
ALKS 5461
Experimental
Sublingual tablet
干预措施: ALKS 5461 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461
时间窗: Up to 168 hours postdose
Area under the plasma concentration versus time curve from time 0 to time of last measureable concentration (AUC0-last) following a single dose of ALKS 5461
时间窗: Up to 168 hours postdose
Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461
时间窗: Up to 168 hours postdose
次要结局
- Time to reach maximum plasma concentration (TMAX)(Up to 168 hours postdose)
- Incidence of adverse events (AEs)(Up to 14 weeks)
- Terminal elimination half-life (T1/2)(Up to 168 hours postdose)
- Apparent clearance (CL/F)(Up to 168 hours postdose)
- Apparent volume of distribution (Vz/F)(Up to 168 hours postdose)
研究者
研究点 (1)
Loading locations...
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