NCT02014259已完成1 期
Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
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
- 71
- 试验地点
- 1
- 主要终点
- Area under the semaglutide plasma concentration time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired renal function compared to subjects with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-85 years (both inclusive) at the time of signing inform consent
- •Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
- •For subject with normal renal function: good general health (as judged by the investigator)
- •Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- •History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- •Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
- •Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2)
- •History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)
研究组 & 干预措施
Subjects with renal impairment
Experimental
干预措施: semaglutide (Drug)
Subjects with normal renal function
Active Comparator
干预措施: semaglutide (Drug)
结局指标
主要结局
Area under the semaglutide plasma concentration time curve
时间窗: From time 0 to 24 hours after the 10th dosing
次要结局
- Maximum observed semaglutide plasma concentration(0 to 24 hours after the 10th dosing)
- Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve(From time 0 to 24 hours after the 10th dosing)
- Maximum observed SNAC plasma concentration(0 to 24 hours after the 10th dosing)
研究者
研究点 (1)
Loading locations...
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