Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
研究概览
简要总结
The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. Previously, we have recruited a cohort of healthy volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to identify genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to study the influence of specific polymorphisms in the intestinal transporters, such as the novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailability of gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit, during which they will take a single dose of gabapentin, and provide blood and urine samples over the course of 36 hours (5 terminal elimination gabapentin half-lives) for pharmacokinetic analysis.
详细描述
Detailed description pending
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have previously participated in the "SOPHIE" study.
- •Subjects will be between the ages of 18 and 40 years old
- •Subjects will have been selected as healthy by medical history questionnaire and screening blood work (CBC, Comprehensive Metabolic panel).
- •Subjects will be taking no regular medications and will have normal renal function.
排除标准
- •Have a new history indicating they are no longer healthy; Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL), will be excluded.
- •Taking a medication that could confound study results
- •Do not consent to participate in the study.
研究组 & 干预措施
Gabapentin
Subjects will take a single dose of 400 mg of gabapentin
干预措施: Gabapentin (Drug)
结局指标
主要结局
Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
时间窗: Gabapentin
To evaluate the bioavailability of Gabapentin in healthy individuals
次要结局
未报告次要终点