NCT00314938

A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	PHA-794428

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-04-17
• Last updated: 2011-05-16

Locations

7 sites across 5 countries: Belgium, France, Germany, Israel, United Kingdom