Effects of Gastric pH on the Pharmacokinetics of Atazanavir in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Atazanavir
研究概览
简要总结
The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of atazanavir in healthy volunteers. The investigators predict that betaine hydrochloride will increase the absorption of atazanavir in volunteers pre-treated with proton-pump inhibitors (PPIs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18-65 years of age
- •Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations
- •BMI between 18.5-30 kg/m2
- •Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen)
- •Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
- •Be able to provide written informed consent and comply with requirements of the study
- •Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until the completion of the entire study
- •Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
- •Fast from food and beverages at least 8 hours prior to medication dosing
- •Be able to read, speak, and understand English
排除标准
- •Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease, or dyspepsia
- •Subjects with a fasting gastric pH of > 4 (i.e. hypochlorhydria)
- •Subjects with a history of dysphagia, achalasia, or difficulty swallowing capsules, tablets, or pills
- •Subjects on prescription or chronic over-the-counter (OTC) medications (including hormonal contraceptives)
- •Subjects with known allergies rabeprazole, any other proton pump inhibitors (PPI's) or betaine hydrochloride
- •Subjects who smoke tobacco
- •Subjects with ongoing alcohol or illegal drug use
- •Subjects who are pregnant, lactating, or attempting to conceive
- •Subjects unable to maintain adequate birth control during the study
研究组 & 干预措施
Ritonavir-boosted Atazanavir
干预措施: Ritonavir-boosted Atazanavir (Drug)
Ritonavir-boosted Atazanavir plus Rabeprazole
干预措施: Ritonavir-boosted Atazanavir plus Rabeprazole (Drug)
Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine HCl
干预措施: Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride (Drug)
结局指标
主要结局
Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Atazanavir
时间窗: Day 4
The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours. Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted atazanavir alone) and tested for statistical significance.
Area-Under-the Concentration Curve from zero-to-infinity (AUC,0-inf) of Atazanavir
时间窗: Day 4
The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-infinite time (0-inf). Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted Atazanavir alone) and tested for statistical significance.
次要结局
- Maximum Concentration of Atazanavir(Day 4)