A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

December 22, 2020 updated by: Novo Nordisk A/S

A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Linz, Austria, 4020
        • Novo Nordisk Investigational Site
      • Wien, Austria, A 1090
        • Novo Nordisk Investigational Site
  • Belgium
      • Brussel, Belgium, 1090
        • Novo Nordisk Investigational Site
      • Bruxelles, Belgium, 1200
        • Novo Nordisk Investigational Site
  • France
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Toulouse cedex 9, France, 31059
        • Novo Nordisk Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • 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
      • Tel Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • Novo Nordisk Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1525
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Esplugues Llobregat(Barcelona), Spain, 08950
        • Novo Nordisk Investigational Site
      • Santiago de Compostela, Spain, 15706
        • Novo Nordisk Investigational Site
      • Vitoria, Spain, 01009
        • Novo Nordisk Investigational Site
  • Sweden
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novo Nordisk Investigational Site
      • Genève, Switzerland, 1211
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml.
  • Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years
  • Body weight above or equal to 16.0 kg and below or equal to 50.0 kg
  • Stable GH replacement treatment for at least 3 months

Exclusion Criteria:

  • History or presence of malignancy
  • Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NNC0195-0092 (somapacitan)
Drug: somapacitan

A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.

Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation.

Other Names:
  • NNC0195-0092
Active Comparator: Norditropin®
Drug: somatropin
Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: From first administration of trial product and up until day 35 (final visit)
From first administration of trial product and up until day 35 (final visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
The area under the insulin-like growth factor I (IGF-I) concentration-time curve
Time Frame: From 0 to 168 hours after dosing
From 0 to 168 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2013

Primary Completion (Actual)

November 4, 2014

Study Completion (Actual)

November 4, 2014

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8640-4042
  • JapicCTI-142663 (Registry Identifier: JAPIC)
  • 2013-000013-20 (EudraCT Number)
  • U1111-1138-2206 (Other Identifier: WHO)
  • REec-2014-0688 (Registry Identifier: Spanish Register of Clinical Studies (REec))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth Hormone Disorder

Clinical Trials on somapacitan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe