NCT02235961已完成1 期
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male 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
- 163
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events recorded
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses of NNC9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, age between (both inclusive) 18 and 55 years at the time of signing inform consent
- •Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m^2
排除标准
- •Thyroid stimulating hormone values outside 0.4-6.0 mIU/l
- •HbA1c (glycated hemoglobin) above or equal to 6.5%
- •Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval corrected by Fridericia formula) interval above 430 ms
- •A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •The use of concomitant medications that prolong the QT/QTc interval
- •Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- •Calcitonin above 50 ng/L
- •History of pancreatitis (acute or chronic)
研究组 & 干预措施
Part 1
Experimental
干预措施: placebo (Drug)
Part 1
Experimental
干预措施: NNC9204-0530 (Drug)
Part 2
Experimental
干预措施: NNC9204-0530 (Drug)
Part 2
Experimental
干预措施: liraglutide (Drug)
Part 2
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events recorded
时间窗: From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)
次要结局
- The terminal half-life of NNC9204-0530(From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points)
- Area under the NNC9204-0530 serum concentration-time curve(From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points)
- Maximum concentration of NNC9204-0530 in serum(From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points)
- The time to maximum concentration of NNC9204-0530 in serum(From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points)
研究者
研究点 (1)
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