NCT02052349已完成1 期
A Phase I, Open-Label Study to Investigate the Regional Bioavailability of ABT-333 When Delivered to Different Sites Within the Gastrointestinal Tract in Healthy Subjects
AbbVie1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- ABT-333 drug concentrations
研究概览
简要总结
This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333 when delivered within different sites of the gastrointestinal tract in 12 healthy subjects.
详细描述
Bioavailability of ABT-333 in different areas of the gut
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- •Subjects must demonstrate their ability to swallow an empty size 000 capsule
- •Must be willing and able to communicate and participate in the whole study
- •Must provide written informed consent
- •Must agree to use an adequate method of contraception
排除标准
- •Participation in a clinical research study within the previous 3 months
- •History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
- •Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at screening and admission)
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic xrays and other medical exposures, exceeding 5 (micro sievert) mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- •Positive hepatitis A virus immunoglobulin M (HAVIgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy (HRT) and hormonal contraception) or herbal remedies in the 14 days before Investigational Medical Product (IMP) administration. Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study by both the Principal Investigator (or delegate) and sponsor's medical monitor
- •Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs >7 days before the first study day, this criterion will be determined on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- •Presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips)
研究组 & 干预措施
Arm 1: ABT-333
Experimental
A single centre, open-label, 4-treatment, 3-period, 4-sequence incomplete randomised, single dose crossover study in healthy subjects.
干预措施: ABT-333 (Drug)
结局指标
主要结局
ABT-333 drug concentrations
时间窗: Day 1 until 24 hours after single dose of ABT-333 for each period
ABT-333 concentrations in blood
次要结局
- Physical Exam(Day-1 until 24 hours after single dose of ABT-333 for each period)
- Electrocardiograms (ECGs)(Day-1 until 3 hours after single dose of ABT-333 for each period)
- Relative bioavailability(Day-1 until 24 hours after single dose of ABT-333 for each period)
- Safety Labs(Day-1 until 24 hours after single dose ABT-333 for each period)
- Number of participants with Adverse Events(Screening until after 7 days after last dose of ABT-333)
研究者
研究点 (1)
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