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