NCT01706783已完成1 期
A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
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
- 35
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD
- •Stable human growth hormone (hGH) replacement therapy for at least 3 months
排除标准
- •Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation
- •Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
- •Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- •Heart insufficiency, New York Heart Association (NYHA) class above 2
- •Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
- •Stable pituitary replacement therapy for less than 3 months
研究组 & 干预措施
NNC0195-0092 (somapacitan)
Experimental
干预措施: somapacitan (Drug)
Norditropin NordiFlex®
Active Comparator
干预措施: Norditropin NordiFlex® (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: From first administration of trial product and up until Day 49
次要结局
- Norditropin NordiFlex® only: AUC (0-24h)(From 0 to 24 hours)
- NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)(From 0 to 168 hours)
- NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)(From 0 to 168 hours)
- Norditropin NordiFlex®: Cmax(From 0 to 24 hours)
- Insulin-like growth factor I (IGF-I): AUC (0-168h)(From 0 to 168 hours)
- IGF-I: Cmax(From 0 to 168 hours)
- Norditropin NordiFlex®, first dose administration only: AUC (0-24h)(From 0 to 24 hours)
- NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)(From 0 to 168 hours)
- Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)(From 0 to 168 hours)
- IGFBP-3: Cmax(From 0 to 168 hours)
研究者
研究点 (1)
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