NCT01973244·Phase 1·INTERVENTIONAL

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

Somapacitan Other Completed

Status

Completed

Phase

Phase 1

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

DRUG

somatropin

Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.

Timeline

From registration to results.

First posted
Oct 31, 2013
Study start
Dec 16, 2013
Primary completion
Nov 4, 2014
Study completion
Nov 4, 2014
Results posted
Not reported
Registry updated
Dec 24, 2020

Outcomes

What the study measures.

Primary outcomes

Incidence of adverse events (AEs)

Time frame · From first administration of trial product and up until day 35 (final visit)

Secondary outcomes

The area under the insulin-like growth factor I (IGF-I) concentration-time curve

Time frame · From 0 to 168 hours after dosing

Eligibility

Who can take part.

Minimum age: 6 Years
Maximum age: 13 Years
Sex: ALL
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)

Study locations

22 registered sites.

Austria · Belgium · France · Israel · North Macedonia · Norway · Slovenia · Spain · Sweden · Switzerland. Showing up to 24 locations stored in the fast local snapshot.