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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00936403

Enrollment

Registered

2009-07-10

Start date

2009-08-31

Completion date

2010-07-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency in Children, Growth Hormone Disorder

Brief 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.

Interventions

DRUGNNC126-0083

One single dose administered in four dose levels in an escalating order

DRUGsomatropin

A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Frequency of Adverse events (AEs)	0-10 days after dosing

Secondary

Measure	Time frame
AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration	Measured 10 days after dosing
IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration	Measured 10 days after dosing

Countries

Belgium, Czechia, Denmark, France, Israel, North Macedonia, Slovenia, Spain, Turkey (Türkiye), United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026