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

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Hormones

Criteria

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