Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Number of treatment emergent adverse events (TEAEs) recorded
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in 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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
- •Age 18-64 years (both inclusive) at the time of signing informed consent
- •BMI (body mass index) 20.0-29.9 kg/m^2 (both inclusive)
排除标准
- •History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
- •Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
研究组 & 干预措施
DC (dosing condition)
Escalation design.
干预措施: NNC0113-0987 (Drug)
DC (dosing condition)
Escalation design.
干预措施: placebo (Drug)
Oral A
Escalation design. Planned end-dose is 5 mg.
干预措施: NNC0113-0987 (Drug)
Oral A
Escalation design. Planned end-dose is 5 mg.
干预措施: placebo (Drug)
Oral B
Escalation design. Planned end-dose is 10 mg.
干预措施: NNC0113-0987 (Drug)
Oral B
Escalation design. Planned end-dose is 10 mg.
干预措施: placebo (Drug)
Oral C
Escalation design. Planned end-dose is 20 mg.
干预措施: NNC0113-0987 (Drug)
Oral C
Escalation design. Planned end-dose is 20 mg.
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs) recorded
时间窗: From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)
次要结局
- Area under the NNC0113-0987 plasma concentration curve(During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69))
- Time to maximum observed NNC0113-0987 plasma concentration(During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69))
- Change in HbA1C (glycosylated haemoglobin)(From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70))
- Change in body weight(From baseline (Day -1) to after 10 weeks of treatment (Day 70))
- Maximum observed NNC0113-0987 plasma concentration(During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69))
- Change in fasting plasma glucose (FPG)(From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70))