NCT01292993已完成1 期
A Phase 1, Randomized, Open-Label, 3-Period, 3-Treatment, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of LX4211 and Metformin 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
- 18
- 试验地点
- 1
- 主要终点
- Plasma concentration of LX4211 and metformin after concurrent single-dose administration
研究概览
简要总结
The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.
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
- •Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.
- •Body mass index (BMI)≥18 to ≤35 kg/sq m
- •Able to provide written consent
- •Vital signs within sponsor-defined ranges
排除标准
- •Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing
- •No investigational agent or study treatment within 30 days prior to Day
- •No protein or antibody-based therapeutic agents within 3 months prior to screening
- •Use of any tobacco product
- •History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption
- •History of any major surgery within 6 months prior to screening
- •History of any serious adverse reaction or hypersensitivity to metformin or LX
- •History of renal disease or significantly abnormal kidney function test
- •History of hepatic disease or significantly abnormal liver function test
- •History of any active infection within 30 days prior to Day 1
- •History of any surgical or medical condition or clinically significant laboratory or physical finding
- •Positive urine glucose at Screening
- •Use of drugs or alcohol
研究组 & 干预措施
Treatment C
Experimental
400 mg LX4211 + 1000 mg metformin
干预措施: 400 mg LX4211 (Drug)
Treatment A
Experimental
400 mg LX4211
干预措施: 400 mg LX4211 (Drug)
Treatment B
Experimental
1000 mg metformin
干预措施: 1000 mg metformin (Drug)
Treatment C
Experimental
400 mg LX4211 + 1000 mg metformin
干预措施: 1000 mg metformin (Drug)
结局指标
主要结局
Plasma concentration of LX4211 and metformin after concurrent single-dose administration
时间窗: Up to 43 days, including screening
次要结局
- Urinary glucose excretion(Up to 43 days, including screening)
- Fasting plasma glucose(Up to 43 days, including screening)
- Postprandial glucose(Up to 43 days, including screening)
- Insulin(Up to 43 days, including screening)
- Peptide YY(Up to 43 days, including screening)
- Glucagon-like peptide (GLP-1)(Up to 43 days, including screening)
- Glucose-dependent insulinotropic peptide(Up to 43 days, including screening)
研究者
研究点 (1)
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