NCT01210404已完成1 期
Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Methadone plasma pharmacokinetic parameters, AUC24, Cmax
研究概览
简要总结
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.
排除标准
- •Evidence of chronic diseases including HIV, HBV or HCV.
- •Evidence of acute or chronic liver disease.
- •Treatment with prescription or nonprescription drugs other than methadone within 7 days.
研究组 & 干预措施
1.0
Experimental
干预措施: filibuvir (Drug)
结局指标
主要结局
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
时间窗: day 11
次要结局
- Methadone plasma pharmacokinetic parameters Tmax and C24h(day 11)
- Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.(day 11)
- Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.(days 0-12)
- Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .(days 0-12)
研究者
研究点 (1)
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