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Completed

NCT Number: NCT00936403

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

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.

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Key information

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NNC126-0083

Drug

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

Somatropin

Drug

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

Primary outcomes

  1. Frequency of Adverse events (AEs)

    Time frame: 0-10 days after dosing

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 10, 2009
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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