NCT01188863已完成1 期
A Phase 1, Randomized, Open-Label, Three-Way Crossover Study of Two Oral Formulations of LX4211 in Subjects With Type 2 Diabetes Mellitus
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
- 15
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration
研究概览
简要总结
This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years of age
- •Males and females of non-childbearing potential
- •Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
- •Fasting plasma glucose ≤240 mg/dL
- •Body mass index <42 kg/sq m
- •HbA1c of 7-11%
- •C-peptide of ≥1.0 ng/mL
- •Ability to provide written informed consent
排除标准
- •History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
- •Current use of any blood glucose-lowering agent other than metformin
- •Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
- •History of HIV, Hepatitis B, or Hepatitis C
- •Surgery within 6 months of screening
- •Donation or loss of >400 mL of blood or blood product within 8 weeks prior to start of study
- •Use of proteins or antibodies within 12 weeks prior to screening. (Flu shots are allowed.)
- •Exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study
- •History of drug or alcohol abuse within 12 months prior to screening.
研究组 & 干预措施
Solid Oral Dose - 150 mg tablets
Experimental
干预措施: 300 mg LX4211 (150 mg tablets) (Drug)
Solid Oral Dose - 50 mg tablets
Experimental
干预措施: 300 mg LX4211 (50 mg tablets) (Drug)
Liquid Oral Dose
Experimental
干预措施: 300 mg LX4211 (liquid) (Drug)
结局指标
主要结局
Maximum observed plasma concentration
时间窗: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Time at which maximum observed plasma concentration occurs
时间窗: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Half-life of the drug in plasma
时间窗: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
次要结局
- Urinary glucose excretion(Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).)
- Plasma glucose(Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.)
- Insulin(Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.)
- Peptide YY(Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.)
- Glucagon-like Peptide 1(Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.)
研究者
研究点 (1)
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