Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts
研究概览
简要总结
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21 years or older
- •provide written informed consent
- •consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers
排除标准
- •History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
- •Currently taking isoniazid
- •Consumption of any alcoholic beverage during the run-in period
- •A detectable serum acetaminophen at baseline
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
- •Platelet count less than 125,000/cc at baseline
- •Positive pregnancy test at baseline (female participants only)
- •Currently adheres to a fasting type diet as determined by self report
- •Currently has anorexia nervosa as determined by self report
- •Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
- •Known hypersensitivity to acetaminophen
研究组 & 干预措施
A
all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
干预措施: acetaminophen (Drug)
结局指标
主要结局
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts
时间窗: Day 0, 4, 7, 9, 11, and 14.
Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.
次要结局
- Alanine Aminotransferase (ALT)(Day 0, 4, 7, 9, 11, and 14.)
研究者
Kennon Heard
Medical Toxicology Fellowship Director
Denver Health and Hospital Authority