A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- PK, IGF-1 and safety measurements up to 2 weeks after dosing
研究概览
简要总结
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling
详细描述
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
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
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Male and female children with a minimum age of 6 years
- •Prepubertal as defined by Tanner staging
- •Growth hormone deficiency
排除标准
- •PGHD patients with uncontrolled pituitary tumor growth
- •Tumors within 3 mm of the optic chiasm
- •Serum ALT and/or AST >= 1.5 times the upper limit of normal range
结局指标
主要结局
PK, IGF-1 and safety measurements up to 2 weeks after dosing
次要结局
- Antibody and IGFBP-3 measurements