NCT01288885已完成1 期
A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of Single Oral Doses of ASP1941 in Healthy Male Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
研究概览
简要总结
This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).
详细描述
This study consists of two parts. Part A is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the PK of ASP1941.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight between 60-100 kg, body mass index (BMI) between 20-30 kg/m2, inclusive
排除标准
- •Fasting Plasma Glucose (FPG) > 6.4 mmol/l
- •HbA1c > 6.2%
- •Pulse <40 or >90 beats per minute; Systolic Blood Pressure (SBP) <90 or >140 mmHg; Diastolic Blood Pressure (DBP) <40 or >95mmHg
结局指标
主要结局
Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
时间窗: Up to 2 weeks after each administration
次要结局
- Pharmacokinetics calculated by ASP1941 plasma concentration change(Up to 72 hours)
- Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine(Up to 72 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy VolunteersHypertensionNCT03128138Shanghai Pharmaceuticals Holding Co., Ltd48
已完成
1 期
Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected SubjectsHIV InfectionNCT02191657ApoPharma26
已完成
1 期
A Study of VIS410 to Assess Safety and PharmacokineticsInfluenzaNCT02045472Visterra, Inc.41
终止
2 期
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ACH-0137171 in Participants With Chronic Hepatitis C InfectionHCV InfectionNCT00401947Alexion Pharmaceuticals, Inc.30
已完成
1 期
A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy VolunteersFibrosisInflammationLiver DiseasesKidney DiseasesIdiopathic Pulmonary FibrosisNon-alcoholic SteatohepatitisNCT04931147Redx Pharma Plc90