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NCT00314938 Clinical Trial

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

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00314938
Other study ID # A6391004
Secondary ID
Status Terminated
Phase Phase 2
First received April 13, 2006
Last updated May 12, 2011
Start date April 2006
Est. completion date November 2007

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

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 information / eligibility
Status Terminated
Enrollment 32
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 12 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PHA-794428

Locations
Country Name City State
Belgium Pfizer Investigational Site Brussel
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Edegem
France Pfizer Investigational Site Paris
Germany Pfizer Investigational Site Erlangen
Israel Pfizer Investigational Site Petach Tikva
United Kingdom Pfizer Investigational Site Cardiff

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Israel,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary PK, IGF-1 and safety measurements up to 2 weeks after dosing
Secondary Antibody and IGFBP-3 measurements
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