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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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01973244
Collaborator
(none)
32
Enrollment
22
Locations
2
Arms
10.6
Actual Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 16, 2013
Actual Primary Completion Date :
Nov 4, 2014
Actual Study Completion Date :
Nov 4, 2014

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [From first administration of trial product and up until day 35 (final visit)]

    Secondary Outcome Measures

    1. The area under the insulin-like growth factor I (IGF-I) concentration-time curve [From 0 to 168 hours after dosing]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Graz Austria 8036
    2 Novo Nordisk Investigational Site Linz Austria 4020
    3 Novo Nordisk Investigational Site Wien Austria A 1090
    4 Novo Nordisk Investigational Site Brussel Belgium 1090
    5 Novo Nordisk Investigational Site Bruxelles Belgium 1200
    6 Novo Nordisk Investigational Site Paris France 75015
    7 Novo Nordisk Investigational Site Toulouse cedex 9 France 31059
    8 Novo Nordisk Investigational Site Haifa Israel 31096
    9 Novo Nordisk Investigational Site Jerusalem Israel 91240
    10 Novo Nordisk Investigational Site Kfar Saba Israel 44281
    11 Novo Nordisk Investigational Site Petah Tikva Israel 49202
    12 Novo Nordisk Investigational Site Tel Hashomer Israel 52621
    13 Novo Nordisk Investigational Site Skopje North Macedonia 1000
    14 Novo Nordisk Investigational Site Bergen Norway 5021
    15 Novo Nordisk Investigational Site Ljubljana Slovenia 1525
    16 Novo Nordisk Investigational Site Barcelona Spain 08035
    17 Novo Nordisk Investigational Site Esplugues Llobregat(Barcelona) Spain 08950
    18 Novo Nordisk Investigational Site Santiago de Compostela Spain 15706
    19 Novo Nordisk Investigational Site Vitoria Spain 01009
    20 Novo Nordisk Investigational Site Stockholm Sweden 141 86
    21 Novo Nordisk Investigational Site Basel Switzerland 4031
    22 Novo Nordisk Investigational Site Genève Switzerland 1211

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01973244
    Other Study ID Numbers:
    • NN8640-4042
    • 2013-000013-20
    • U1111-1138-2206
    • REec-2014-0688
    • JapicCTI-142663
    First Posted:
    Oct 31, 2013
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Dwarfism, Pituitary
    Endocrine System Diseases

    Study Results

    No Results Posted as of Dec 24, 2020