NCT01042106已完成1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and 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
- 40
- 试验地点
- 1
- 主要终点
- Safety assessments include physical examination, laboratory variables and ECG.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic subjects
- •Age ≥ 18 and ≤ 65 years
- •Body Mass Index ≤45
- •Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug
- •Inclusion Criteria: Healthy subjects
- •Age ≥ 18 and ≤ 65 years
- •Body Mass Index ≥ 18 and ≤ 29
- •Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.
排除标准
- •Diabetic subjects
- •Have a current or expected requirement for any antidiabetic or lipid-lowering drug
- •Exclusion Criteria: Healthy subjects
- •Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer
研究组 & 干预措施
DSP-8658
Experimental
DSP-8658 2.5, 10, 20, 40 mg once daily
干预措施: DSP-8658 (Drug)
Placebo
Placebo Comparator
Placebo 2.5, 10, 20, and 40 mg doses once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessments include physical examination, laboratory variables and ECG.
时间窗: 20 days
次要结局
- Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study.(20 days)
- Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study.(18 days)
研究者
研究点 (1)
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