NCT00936403

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Growth Hormone Disorder
• Growth Hormone Deficiency in Children

Interventions

Type	Name	Description
DRUG	NNC126-0083	One single dose administered in four dose levels in an escalating order
DRUG	somatropin	A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-07-10
• Last updated: 2017-02-08

Locations

21 sites across 10 countries: Belgium, Czechia, Denmark, France, Israel, North Macedonia, Slovenia, Spain, Turkey (Türkiye), United Kingdom