Growth Hormone Deficiency
Conditions
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.
Interventions
DRUGPHA-794428
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 1.Male and female children with a minimum age of 6 years * 2\. Prepubertal as defined by Tanner staging * 3\. Growth hormone deficiency
Exclusion criteria
* 1\. PGHD patients with uncontrolled pituitary tumor growth * 2\. Tumors within 3 mm of the optic chiasm * 3\. Serum ALT and/or AST \>= 1.5 times the upper limit of normal range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK, IGF-1 and safety measurements up to 2 weeks after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody and IGFBP-3 measurements | — |
Countries
Belgium, France, Germany, Israel, United Kingdom
Outcome results
None listed