NCT00715689已完成2 期
Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Safety and tolerability (adverse events, local tolerability, physical examination)
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
- •Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
- •GH replacement therapy for more than 3 months
- •Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive
排除标准
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- •Malignant disease
- •Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- •Heart insufficiency, NYHA class greater than 2
- •Subjects with diabetes with an HbA1C above 8.0%
- •Diabetic receiving insulin treatment
- •Stable pituitary replacement therapy for less than 3 months
- •Impaired liver function
- •Impaired kidney function
研究组 & 干预措施
B
Experimental
干预措施: placebo (Drug)
A
Experimental
干预措施: NNC126-0083 (Drug)
A
Experimental
干预措施: placebo (Drug)
B
Experimental
干预措施: NNC126-0083 (Drug)
C
Experimental
干预措施: NNC126-0083 (Drug)
C
Experimental
干预措施: placebo (Drug)
D
Experimental
干预措施: NNC126-0083 (Drug)
D
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability (adverse events, local tolerability, physical examination)
时间窗: 0 to 10 days after third dosing, (day 15-25 after first dose)
次要结局
- Cmax, maximum concentration of IGF-I(after trial product administration)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083Growth Hormone DisorderHealthyNCT00722540Novo Nordisk A/S40
已完成
1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01866748Novo Nordisk A/S170
已完成
1 期
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01690169Novo Nordisk A/S45
已完成
1 期
Safety and Tolerability of NN9068 in Healthy Male VolunteersHealthyDiabetesNCT00983021Novo Nordisk A/S24
已完成
1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy SubjectsHealthyDiabetesNCT01978613Novo Nordisk A/S100