A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Urinary glucose excretion
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals 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
- •Adults ≥18 and ≤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
- •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 Day 1
- •Use of any protein or antibody-based therapeutic agents within 3 months of Screening
- •Prior exposure to any SGLT inhibitor
- •Use of 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 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 30 days of Day 1
- •History of alcohol or substance abuse within 2 years prior to Day 1
- •Positive urine glucose at Screening
- •Positive pregnancy test at Screening
- •Inability or difficulty swallowing whole tablets or capsules
- •Unable or unwilling to communicate or cooperate with the Investigator.
研究组 & 干预措施
LX4211
400 mg of LX4211 administered orally
干预措施: Schedule A (Drug)
LX4211
400 mg of LX4211 administered orally
干预措施: Schedule B (Drug)
LX4211
400 mg of LX4211 administered orally
干预措施: Schedule C (Drug)
LX4211
400 mg of LX4211 administered orally
干预措施: Schedule D (Drug)
LX4211
400 mg of LX4211 administered orally
干预措施: Schedule E (Drug)
Placebo
Nonidentical placebo administered orally
干预措施: Schedule A (Drug)
Placebo
Nonidentical placebo administered orally
干预措施: Schedule B (Drug)
Placebo
Nonidentical placebo administered orally
干预措施: Schedule C (Drug)
Placebo
Nonidentical placebo administered orally
干预措施: Schedule D (Drug)
Placebo
Nonidentical placebo administered orally
干预措施: Schedule E (Drug)
结局指标
主要结局
Urinary glucose excretion
时间窗: 24 hours collection on Day -1 and Days 7-13
Fasting Plasma Glucose
时间窗: Day -1 and Days 7-12
Postprandial Glucose
时间窗: Day -1 and Days 7-12
Insulin
时间窗: Day -1 and Days 7-12
Glucagon-like peptide 1 (total and active)
时间窗: Day -1 and Days 7-12
Peptide YY
时间窗: Day -1 and Days 7-12
次要结局
- Number of Participants with Adverse Events(Day 1 to Day 14)
- Blood chemistry(Day -2, Day 7 and Day 13)
- Hematology(Day -2, Day 7 and Day 13)