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:
Participant gender:
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