NCT01411800已完成1 期
A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human 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
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Urinary 5-HIAA levels
研究概览
简要总结
The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects age 18 to 55 years
- •Vital signs acceptable at Screening
- •Body mass index (BMI) between 18 and 35 kg/m^2 at Screening
- •Considered to be in good health, as determined by the Investigator
- •Normal ECG findings
- •Negative urine screen for drugs of abuse and negative breath test for alcohol
- •Negative hepatitis B surface antigen, hepatitis C antibody, and HIV1 and HIV2 antibody tests within the last 28 days
- •Ability to provide written informed consent
排除标准
- •Use of any medication (including acetaminophen) within 5 days of dosing
- •Use of any investigational agent or selective serotonin reuptake inhibitors (SSRIs) within 30 days of study start
- •Administration of any protein or antibodies within 90 days of study start
- •Donation or loss of greater than 450 mL of blood within 45 days of study start
- •Known history of hepatic disease or significantly abnormal liver function tests
- •History of alcoholism or substance abuse within 3 years prior to study start
- •Participation in any other clinical study within 30 days preceding the first dose of study drug
- •Positive serum pregnancy test
研究组 & 干预措施
Treatment A
Experimental
500 mg LX1033, capsules administered two times per day orally
干预措施: 250 mg capsule (Drug)
Treatment B
Experimental
500 mg LX1033, tablets administered two times per day orally
干预措施: 250 mg tablets (Drug)
结局指标
主要结局
Urinary 5-HIAA levels
时间窗: 34 days
Plasma 5-HIAA levels
时间窗: 30 days
次要结局
- Maximum observed plasma concentration(32 days)
- Time at which maximum observed plasma concentration occurs(32 days)
- Half-life of the drug in plasma(32 days)
研究者
研究点 (1)
Loading locations...
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