A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
- Conditions
- Growth Hormone Deficiency
- Registration Number
- NCT00314938
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- 1.Male and female children with a minimum age of 6 years
-
- Prepubertal as defined by Tanner staging
-
- Growth hormone deficiency
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PK, IGF-1 and safety measurements up to 2 weeks after dosing
- Secondary Outcome Measures
Name Time Method Antibody and IGFBP-3 measurements
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Cardiff, United Kingdom