NCT02557620已完成1 期
A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
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
- 113
- 试验地点
- 1
- 主要终点
- Area under the semaglutide concentration-time curves
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly 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
- Double (Participant, Investigator)
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
- •Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator
- •Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
- •HbA1c (glycosylated haemoglobin) below 6.5%
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)
- •Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
- •History of pancreatitis (acute or chronic)
- •Screening calcitonin equal or above 50 ng/L
- •Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
研究组 & 干预措施
semaglutide OD + placebo semaglutide OW
Experimental
干预措施: semaglutide (Drug)
semaglutide OD + placebo semaglutide OW
Experimental
干预措施: placebo (Drug)
placebo semaglutide OW + placebo semaglutide OD
Placebo Comparator
干预措施: placebo (Drug)
semaglutide OW + placebo semaglutide OD
Experimental
干预措施: semaglutide (Drug)
semaglutide OW + placebo semaglutide OD
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Area under the semaglutide concentration-time curves
时间窗: At steady-state from 0 to168 hours after dosing on day 78
次要结局
- Area under the the single dose concentration-time curve(From 0 to 300 min after administration of paracetamol (1.5 g) at day 79)
- Maximum observed semaglutide plasma concentration(At steady-state derived from the concentration-time curves, within 168 hours from day 78)
- Number of treatment emergent adverse events (TEAEs)(From baseline (day 1, post-dose) to last follow-up visit (day 120))
研究者
研究点 (1)
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