NCT01916863已完成1 期
A Phase 1, Single-center, Partially Double-blind, Randomized, Single-dose, 3-Period Crossover Study to Assess the Pharmacodynamic Effects of LX4211 and INVOKANA™ (Canagliflozin) in Healthy Subjects Using Stable Isotope Tracer Methods
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
- Change from baseline in rate of glucose appearance after meal (RaO)
研究概览
简要总结
The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.
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
- 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 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 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 7 days of dosing
- •Use of any investigational agent or study treatment within 30 days of Day -1
- •Use of any protein or antibody-based therapeutic agents within 3 months of Screening
- •Prior exposure to LX4211 or canagliflozin
- •Daily use of >5 cigarettes or any tobacco products within 6 weeks prior to Screening and while participating in the study
- •History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
- •History of bowel resection, any malabsorptive disorder, severe gastroparesis, any GI procedure for the purpose of weight loss which would slow gastric emptying
- •History of any major surgery within 6 months prior to Screening
- •History of any hypersensitivity to the inactive components of LX4211, inactive components of canagliflozin, acetaminophen oral solution or any inactive component of acetaminophen liquid preparation
- •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 30 days prior to Day -1
- •History of alcohol or substance abuse within 2 years prior to Day 1
- •History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
- •Donation or loss of >500 mL of blood or blood product within 56 days of Day -1
- •positive pregnancy test at Screening or Day -1
- •Positive urine screen for drugs of abuse at Screening or Day -1
- •Positive breath test for alcohol at Screening or Day -1
- •Inability or difficulty swallowing whole tablets
- •Unable or unwilling to communicate or cooperate with the Investigator
研究组 & 干预措施
LX4211
Experimental
400 mg of LX4211
干预措施: LX4211 400 mg (Drug)
LX4211
Experimental
400 mg of LX4211
干预措施: canagliflozin 300 mg (Drug)
LX4211
Experimental
400 mg of LX4211
干预措施: LX4211 Placebo (Drug)
Canagliflozin
Active Comparator
300 mg canagliflozin
干预措施: LX4211 400 mg (Drug)
Canagliflozin
Active Comparator
300 mg canagliflozin
干预措施: canagliflozin 300 mg (Drug)
Canagliflozin
Active Comparator
300 mg canagliflozin
干预措施: LX4211 Placebo (Drug)
Placebo
Placebo Comparator
LX4211 placebo
干预措施: LX4211 400 mg (Drug)
Placebo
Placebo Comparator
LX4211 placebo
干预措施: canagliflozin 300 mg (Drug)
Placebo
Placebo Comparator
LX4211 placebo
干预措施: LX4211 Placebo (Drug)
结局指标
主要结局
Change from baseline in rate of glucose appearance after meal (RaO)
时间窗: Days 1, 8, 15
次要结局
- Rate of total glucose appearance (RaT)(Days 1, 8, 15)
- Change from baseline in fasting plasma glucose(Days 1, 8, 15)
- Change from baseline in postprandial glucose(Days 1, 8, 15)
- Change from baseline in insulin(Days 1, 8, 15)
研究者
研究点 (1)
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