Influence of CYP3A Modulation on Buprenorphine Disposition and Clinical Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Plasma Cmax of Buprenorphine
研究概览
简要总结
To evaluate role of CYP3A in buprenorphine disposition and effect
详细描述
Subjects will be studied during a maximum of seven occasions.
Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.
Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each subject must meet all of the following criteria:
- •Male or non-pregnant female volunteer, 18-50 yr old
- •Good general health with no known major medical conditions
- •Provide informed consent
排除标准
- •Subjects will not be enrolled if any of the following criteria exist:
- •Known history of liver or kidney disease
- •Use of prescription or non-prescription medications, herbals or foods known to be metabolized by or affect CYP3A activity (this includes the use of oral contraceptives).
- •Females who are pregnant or nursing
- •Known history of drug or alcohol addiction (prior or present addiction or addiction treatment)
- •Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)
研究组 & 干预措施
Healthy males and non-pregnant females
Subjects will be studied during a maximum of seven occasions.
Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.
Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
干预措施: Buprenorphine Control (Drug)
Healthy males and non-pregnant females
Subjects will be studied during a maximum of seven occasions.
Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.
Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
干预措施: Buprenorphine + Rifampin (Drug)
Healthy males and non-pregnant females
Subjects will be studied during a maximum of seven occasions.
Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.
Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
干预措施: Buprenorphine + Grapefruit juice (Drug)
Healthy males and non-pregnant females
Subjects will be studied during a maximum of seven occasions.
Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.
Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
干预措施: Buprenorphine + Ketoconazole (Drug)
结局指标
主要结局
Plasma Cmax of Buprenorphine
时间窗: 96 hr
次要结局
未报告次要终点