A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Blood levels of telaprevir
研究概览
简要总结
The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir.
Telaprevir, in combination with other antiviral agents, is being investigated for the treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for maintainance therapy in patients with opioid dependence.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between the ages of 18 and 64 years, inclusive. Females must be of non-childbearing potential.
- •Receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening.
排除标准
- •Illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine).
- •Treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer.
- •Blood donation of 500 mL or more within the last 56 days.
- •Infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
研究组 & 干预措施
Open-Label Arm
The treatment period will include 3 phases:
- 14 day run-in period
- 7 day co-administration period
- 31 day follow-up period
干预措施: telaprevir (Drug)
Open-Label Arm
The treatment period will include 3 phases:
- 14 day run-in period
- 7 day co-administration period
- 31 day follow-up period
干预措施: buprenorphine/naloxone (Drug)
结局指标
主要结局
Blood levels of telaprevir
时间窗: Day 1 through Day 7
Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Blood levels of buprenorphine
时间窗: Day -4 through Day 38
Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Blood levels of norbuprenorphine
时间窗: Day -4 through Day 38
Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Blood levels of naloxone
时间窗: Day -1 and Day 7
Measured by maximum observed concentration (Cmax)
次要结局
- Safety and tolerability(Day -14 through Day 38)
- Buprenorphine withdrawal symtoms(Day -2 through Day 38)