Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Pharmacokinetic profiles of growth hormone
研究概览
简要总结
This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions:A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously
详细描述
The subjects will attend a screening visit and four treatment sessions. The dosing visits will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay for the infusion group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AGHD male or female subjects
- •Stable GH replacement therapy for at least 3 months
- •Body Mass Index 18,5 to 35.0 kg/m2
- •Achieved final height
- •Age ≥ 18 years
排除标准
- •Known or suspected allergy to trial product or components of the trial product
- •Subjects with active malignancy
- •Severe cardiac insufficiency classified according to NYHA III-IV
- •Unstable angina pectoris, acute myocardial infarction within the last 12 months
- •Severe, uncontrolled hypertension: sitting blood pressure > 180/110 mmHg
- •HbA1C > 7,5 %
- •Impaired kidney function: plasma creatinine ≥ 150 umol/l according to the hospital lab.
- •Impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab.
- •Patients on insulin treatment
- •Stable pituitary replacement therapy for less than 3 months
- •Participation in any other clinical trial involving any investigational products within the last three months prior to this trial
- •Any diseases judged by the investigator that could affect the trial
- •Women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. Women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, IUD or who had not undergone hysterectomy or sterilization
研究组 & 干预措施
Norditropin SimpleXx sc bolus injection
Single sc bolus injection of 3 mg growth hormone without interval exercise
干预措施: Norditropin SimpleXx (growth hormone) (Drug)
Norditropin SimpleXx single sc injection
Single sc bolus injection of 3 mg growth hormone with interval exercise
干预措施: Norditropin SimpleXx (growth hormone) (Drug)
Norditropin SimpleXx contin. sc infusion
Continuous sc infusion of 3 mg growth hormone without interval exercise
干预措施: Norditropin SimpleXx (growth hormone) (Drug)
Norditropin SimpleXx cont. sc infusion
Continuous sc infusion of 3 mg growth hormone with interval exercise
干预措施: Norditropin SimpleXx (growth hormone) (Drug)
结局指标
主要结局
Pharmacokinetic profiles of growth hormone
时间窗: 48 hours
Pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as a bolus in the adult patients with growth hormone deficiency during interval exercise or in supine rest.
次要结局
- Pharmacokinetic profiles of growth hormone(60 hours)
研究者
Jurgita Janukonyte
Medical doctor
Aarhus University Hospital