NCT00959634已完成1 期
Pharmacokinetic Study of ABT-126 in Healthy Volunteers
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
- 20
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)
研究概览
简要总结
This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between 18 and 50 years of age
- •If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
- •If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration
排除标准
- •Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis
- •History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder
- •Presence of any uncontrolled medical illness
研究组 & 干预措施
1
Experimental
Dose 1 BID
干预措施: ABT-126 (Drug)
2
Experimental
Dose 2 BID
干预措施: ABT-126 (Drug)
3
Placebo Comparator
Placebo BID
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)
时间窗: One day before dosing through day of last dose and up to 6 days after last dose
ABT-126 levels in blood (plasma)
时间窗: First dose through last dose and up to 192 hours after last dose
次要结局
未报告次要终点
研究者
研究点 (1)
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