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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children
• Intervention / Treatment: Drug: NNC126-0083; Drug: somatropin

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Novo Nordisk Investigational Site
  • Gent, Belgium, 9000
    • Novo Nordisk Investigational Site
• Czech Republic
  • Prague 5, Czech Republic, 15018
    • Novo Nordisk Investigational Site
• Denmark
  • Århus C, Denmark, 8000
    • Novo Nordisk Investigational Site
• France
  • BRON cedex, France, 69677
    • Novo Nordisk Investigational Site
  • Toulouse cedex 9, France, 31059
    • Novo Nordisk Investigational Site
• Israel
  • Beer Sheva, Israel, 84101
    • Novo Nordisk Investigational Site
  • Jerusalem, Israel, 91240
    • Novo Nordisk Investigational Site
  • Kfar Saba, Israel, 44281
    • Novo Nordisk Investigational Site
  • Petah Tikva, Israel, 49202
    • Novo Nordisk Investigational Site
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • Novo Nordisk Investigational Site
• Slovenia
  • Ljubljana, Slovenia, 1525
    • Novo Nordisk Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • Novo Nordisk Investigational Site
  • Esplugues Llobregat, Spain, 08950
    • Novo Nordisk Investigational Site
  • Santiago de Compostela, Spain, 15706
    • Novo Nordisk Investigational Site
  • Vitoria, Spain, 01009
    • Novo Nordisk Investigational Site
• Turkey
  • Ankara, Turkey, 06100
    • Novo Nordisk Investigational Site
  • Ankara, Turkey
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34093
    • Novo Nordisk Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Novo Nordisk Investigational Site
  • Cambridge, United Kingdom, CB2 2QQ
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Norditropin NordiFlex®	Drug: somatropin; A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant
Experimental: NNC126-0083	Drug: NNC126-0083; One single dose administered in four dose levels in an escalating order

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
• de Schepper J, Rasmussen MH, Gucev Z, Eliakim A, Battelino T. Long-acting pegylated human GH in children with GH deficiency: a single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics. Eur J Endocrinol. 2011 Sep;165(3):401-9. doi: 10.1530/EJE-11-0536. Epub 2011 Jul 1.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: July 9, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NN8630-1824; 2008-008240-25 (EudraCT Number)