An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Systemic concentration & AUC of study drug
研究概览
简要总结
This study will investigate how 3 new types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study involves all volunteers receiving all 3 different formulations, as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.
详细描述
The present study will investigate the tolerability and pharmacokinetics of single oral doses of firategrast administered as the existing immediate release tablet formulation and as three modified release tablet formulations designed to release drug over differing relase rates. The range of release rates is expected to give preliminary information on the performance of a matrix modified release formulation for use in future efficacy studies.
Subjects will receive each formulation in the fasted state in a randomised 4-part single dose crossover fashion. Based on the review of pharmacokinetic data from at least the first two study sessions, subjects may also receive a fifth dose of firategrast, administered after a high fat meal. The formulation administered with food will be chosen based upon pharmacokinetic data from previous dose sessions. Doses administered will be different with respect to gender; the doses are expected to result in similar exposures across the genders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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, aged 18 to 65 yrs inclusive
- •Healthy, as determined by study physician
- •Capable of giving informed consent
排除标准
- •Positive drugs of abuse result
- •Positive for HIV or Hepatitis B and/or C viruses
- •History of alcohol consumption in excess of average recommended weekly intake (more than 21 units for males, more than 14 units for females)
- •Participation in a clinical trial within 90 days of scheduled first dose
研究组 & 干预措施
Firategrast XRA
Low extended release tablet
干预措施: B (Drug)
Firategrast XRB
Medium extended releast tablet
干预措施: C (Drug)
Firategrast XRC
High extended release tablet
干预措施: D (Drug)
Firategrast IR
Immediate Release reference tablet
干预措施: A (Drug)
结局指标
主要结局
Systemic concentration & AUC of study drug
时间窗: pre-dose, up to 120 hours after each single dose
次要结局
- Adverse events(from screening, through study day, and up to follow-up visit. Spontaneous reporting)
- Systemic concentration & AUC of study drug metabolite(pre-dose, up to 120 hours after each single dose)
- Vital signs(screening, pre-dose, up-to 15 hours post does, follow-up visit)
- 12-lead Electrocardiogram(screening, pre-dose and up to 8 hours post dose, then at follow-up)
- Heamatology, clinical chemistry and Uninalysis(screening, predose, up-to 8 hours post dose, follow-up)