NCT01916850已完成1 期
A Phase 1b, Single-center, Double-blind, Randomized, Placebo-controlled Study on the Safety, Tolerability, and Pharmacokinetic Effects of Multiple Doses of LX4211 400 mg qd and LX4211 800 mg qd 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
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive 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
- •Adult subjects ≥ 18 to ≤ 55 years of age
- •Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
- •Body mass index (BMI) ≥18 and ≤35 kg/sq m
- •Willing and able to provide written informed consent
排除标准
- •Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
- •Use of any investigational agent or study treatment within 30 days of dosing
- •Use of any protein or antibody-based therapeutic agents within 3 months of Screening
- •Prior exposure to LX4211
- •Use of cigarettes or any tobacco products within 2 months prior to Screening and while participating in the study
- •History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
- •History of any major surgery within 6 months of Screening
- •History of any hypersensitivity to the inactive components of LX4211
- •History of renal disease or significantly abnormal kidney function tests
- •History of hepatic disease or significantly abnormal liver function tests
- •History of any active infection within 14 days prior to Day 1
- •History of alcohol or substance abuse within 2 years prior to Day 1
- •Donation or loss of >400 mL of blood or blood product within 3 months of dosing
- •Positive urine glucose at Screening
- •Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
- •Inability or difficulty swallowing pills
- •Unable or unwilling to communicate or cooperate with the Investigator
研究组 & 干预措施
LX4211 Low Dose
Experimental
400 mg of LX4211 administered once daily for 10 consecutive days
干预措施: LX4211 400 mg (Drug)
LX4211 High Dose
Experimental
800 mg of LX4211 administered once daily for 10 consecutive days
干预措施: LX4211 800 mg (Drug)
Placebo
Placebo Comparator
Identical placebo administered once daily for 10 consecutive days
干预措施: LX4211 Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to Day 10
次要结局
- Area under the curve(Days 1 through 10)
研究者
研究点 (1)
Loading locations...
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