A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.

Inclusion Criteria:

• Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
• Pre-pubertal children
• Growth hormone replacement treatment for at least three months

Exclusion Criteria:

• Evidence of tumour growth or malignant disease
• Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)