NCT01008059已完成不适用
Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
研究概览
简要总结
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female, 18-40 yr. old
- •Good general health with no remarkable medical conditions such as liver, kidney, heart, or lung failure
- •BMI between 20-33
- •Provide informed consent
排除标准
- •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 (including oral birth control medications)
- •Females who are pregnant or nursing
- •Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
- •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).
- •History of bradycardia
- •Respiratory rate <10
- •History of significant pulmonary disease
- •History of pre-existing medical condition predisposing to respiratory depression
- •Systolic blood pressure <100 mgHg and diastolic blood pressure <70mmHg
研究组 & 干预措施
Alfentanil
Experimental
Alfentanil (0.5-1 mg IV bolus) followed 3 hours later or simultaneously by 1-4 mg oral deuterium-labeled (d3) alfentanil on each study visit.
干预措施: Alfentanil (Drug)
结局指标
主要结局
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
时间窗: 9 hours
AUC(0-inf)
次要结局
未报告次要终点
研究者
研究点 (1)
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