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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Pfizer

Current Primary Outcome: PK, IGF-1 and safety measurements up to 2 weeks after dosing

Original Primary Outcome: Same as current

Current Secondary Outcome: Antibody and IGFBP-3 measurements

Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: April 13, 2006
Date Started: April 2006
Date Completion:
Last Updated: May 12, 2011
Last Verified: May 2011