A trial investigating the 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

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2013-000013-20-SI
• Date of registration: 20/09/2013
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A trial investigating the 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
• Scientific 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
• Date of first enrolment: 09/12/2013
• Target sample size: 32
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000013-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Dose escalation If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Austria, Belgium, European Union, Israel, Macedonia, the former Yugoslav Republic of, Norway, Slovenia, Spain, Sweden, Switzerland

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
- Confirmed diagnosis of GHD as defined by two different GH stimulation tests, peak GH level = 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 = 7.0 ng/mL.
- Pre-pubertal children at screening:
- Boys: Tanner stage 1 and age = 6 year and < 13 years
- Girls: Tanner stage 1 and age = 6 year and < 12 years
- Body weight =16.0 kg and =50.0 kg
- Stable GH replacement treatment = 3 months

Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- History or presence of malignancy
- Overt diabetes mellitus (fasting blood glucose = 7.0 mmol/L)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Growth hormone deficiency in children
MedDRA version: 14.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders

Intervention(s)

Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: n/a
CAS Number: 1338578-34-9
Other descriptive name: NNC0195-0092
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Trade Name: Norditropin SimpleXx 10 mg
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Other descriptive name: SOMATROPIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Primary Outcome(s)

Primary end point(s): Incidence of adverse events (AEs)

Main Objective: To evaluate safety and tolerability of a single subcutaneous (s.c.) dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with growth hormone deficiency (GHD)

Timepoint(s) of evaluation of this end point: From first administration of trial product and up until day 35 (final visit)

Secondary Objective: - To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of a single s.c. dose of NNC0195-0092 in children with GHD
- To evaluate local tolerability (i.e. injection site reactions) of a single s.c. dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with GHD

Secondary Outcome(s)

Secondary end point(s): The area under the insulin-like growth factor I (IGF-I) concentration-time curve

Timepoint(s) of evaluation of this end point: From 0 to 168 hours after dosing

Secondary ID(s)

NN8640-4042

Source(s) of Monetary Support

Novo Nordisk A/S