NCT02508506已完成1 期
A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS5461 in Subjects With Renal 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
- 22
- 试验地点
- 2
- 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 renal 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 79 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 18.0-40.0 kg/m^2 and a total body weight >50kg
- •Agrees to use an approved method of contraception for the duration of the study
- •Additional criteria may apply
- •For subjects with renal impairment:
- •Has severe or end stage renal disease, and does not require dialysis
- •Has stable renal function for at least 60 days preceding screening
- •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 renal impairment
- •Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, 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 my apply
- •For subjects with renal impairment:
- •Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis
- •Has received a kidney transplant
- •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 measurable 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
- Apparent volume of distribution (Vz/F)(up to 168 hours postdose)
- Safety: Incidence of adverse events (SAE)(Up to 12 days)
- Time to reach maximum plasma concentration (TMAX)(up to 168 hours postdose)
- Terminal elimination half-life (T1/2)(up to 168 hours postdose)
- Apparent clearance (CL/F)(up to 168 hours postdose)
研究者
研究点 (2)
Loading locations...
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