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

Phase 1

Completed

• Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children
• Interventions: Drug: somapacitan; Drug: somatropin

• Registration Number: NCT01973244
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Study Start: 2013-12-16
• Primary Completion: 2014-11-04
• Study Completion: 2014-11-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0195-0092 (somapacitan)	somapacitan	-
Norditropin®	somatropin	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	From first administration of trial product and up until day 35 (final visit)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇭 Genève, Switzerland