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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01973244
First received: October 22, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.


Condition Intervention Phase
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Drug: NNC0195-0092
Drug: somatropin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: From first administration of trial product and up until day 35 (final visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The area under the insulin-like growth factor I (IGF-I) concentration-time curve [ Time Frame: From 0 to 168 hours after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC0195-0092 Drug: NNC0195-0092

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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973244

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

Locations
Austria
Recruiting
Wien, Austria, A 1090
Belgium
Recruiting
Brussels, Belgium, 1090
France
Recruiting
Paris, France, 75015
Israel
Recruiting
Petah Tikva, Israel, 49202
Macedonia, The Former Yugoslav Republic of
Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Norway
Recruiting
Bergen, Norway, 5021
Slovenia
Recruiting
Ljubljana, Slovenia, 1525
Spain
Recruiting
Vitoria, Spain, 01009
Sweden
Recruiting
Stockholm, Sweden, 141 86
Switzerland
Recruiting
Basel, Switzerland, 4031
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01973244     History of Changes
Other Study ID Numbers: NN8640-4042, 2013-000013-20, U1111-1138-2206
Study First Received: October 22, 2013
Last Updated: February 25, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Macedonia, The Former Yugoslav Republic of: Ministry of Health
Norway: Norwegian Medicines Agency
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Federal Office of Public Health

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014