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

Novo Nordisk A/S31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Interventions

NNC126-0083DRUG

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

somatropinDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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)

Locations (21)

Novo Nordisk Investigational Site

Brussels, Belgium

Novo Nordisk Investigational Site

Ghent, Belgium

Outcomes

Primary Outcomes

Frequency of Adverse events (AEs)

Time frame: 0-10 days after dosing

Secondary Outcomes

AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration

Time frame: 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

Time frame: Measured 10 days after dosing

Data from ClinicalTrials.gov

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