NCT00854659已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects
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
- Abbott
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of three different strengths of an investigational product dosed twice a day over 7 days in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females with a condition of general good health.
- •Must be willing to participate in all study-related procedures.
排除标准
- •History of significant sensitivity to any drug.
- •Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives.
- •A requirement for medications, vitamins and/or herbal supplements during the study.
- •Pregnant or breast-feeding.
- •History of drug or alcohol abuse.
- •Positive Hepatitis or HIV test.
- •History of certain medical conditions or any uncontrolled medical illness.
- •History of certain gastrointestinal surgeries that may interfere with gastrointestinal motility, PH or absorption.
- •Current participation in another clinical study or receipt of investigational drug within the past 6 weeks.
研究组 & 干预措施
1
Active Comparator
ABT-102 Tablets, 4 mg BID
干预措施: ABT-102 (Drug)
2
Active Comparator
ABT-102 Tablets BID, escalating dose
干预措施: ABT-102 (Drug)
3
Active Comparator
ABT-102 Tablets BID, escalating dose
干预措施: ABT-102 (Drug)
4
Placebo Comparator
Placebo Tablets, BID
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
时间窗: 10 days
To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.
时间窗: 10 days
次要结局
- Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects.(10 days)
研究者
研究点 (1)
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