Food-Effect on Bioavailability of Cystagon™ in Normal, Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Peak Plasma Cysteamine Concentration (Cmax)
研究概览
简要总结
In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the rare disease cystinosis that became available in 1994, but there is inadequate knowledge of the food-effect on this drug's bioavailability. This study aims to investigate how food affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI > 18 and < 30.
- •Females of childbearing potential who are sexually active must be willing to use two forms of contraceptive methods throughout the study and for 14days after the last study drug administration.
- •Minimum weight of 50 kg.
- •Good health, defined as not having history of any chronic illness and not requiring any regular medication/therapy.
- •Must swallow tablets on a regular basis.
排除标准
- •Evidence of Helicobacter pylori infection, presently, or within the last year.
- •Subjects with known hypersensitivity to cysteamine.
- •History, currently or within the past 3 months, of the following conditions:
- •Pancreatitis
- •Inflammatory bowel disease
- •Malabsorption
- •Severe liver disease
- •Unstable heart disease, e.g., myocardial infarction, heart failure, arrhythmias.
- •Unstable diabetes mellitus
- •Any bleeding disorder.
- •Zollinger-Ellison syndrome
- •Malignant disease
- •Subjects whom may be pregnant or have health issues that make it unsafe for them participate, or whose concomitant medical problems preclude them from committing to the study schedule.
- •Use of an investigational drug within 30 days (or 90 days for biologics) prior to dosing.
- •Use of prescription medication within 14 days prior to the first dosing;
- •Use over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing.
- •Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
- •Hemoglobin <13.5 g/dL (males) and <12.0 g/dL (females) and hematocrit <41.0% (males) and <36.0% (females) at screening.
- •Breast-feeding subject.
- •Immunization with a live attenuated vaccine 1 month prior to dosing or planned vaccination during the course of the study.
- •Presence of fever (body temperature >37.6°C) (e.g. a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
研究组 & 干预措施
Cysteamine bitartrate
Cysteamine bitartrate, 500mg once a day, three days.
干预措施: Cysteamine bitartrate (Drug)
结局指标
主要结局
Peak Plasma Cysteamine Concentration (Cmax)
时间窗: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post-dose
Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II \& III visits.
Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC)
时间窗: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post-dose
Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II \& III visits.
Time to Peak Plasma Cysteamine Concentration (Tmax)
时间窗: 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post-dose
Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II \& III visits.
次要结局
未报告次要终点
研究者
Ranjan Dohil
Principal Investigator
University of California, San Diego