NCT01973244|CompletedPhase 1

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

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

Novo Nordisk A/S ClinicalTrials.gov

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5 other identifiers

NN8640-40422013-000013-20U1111-1138-2206REec-2014-0688JapicCTI-142663

Study Type

interventional

Target

Locations

9 countries

Sites

Timeline

RegisteredOct 2013

StartedDec 2013

CompletionNov 2014

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Dec 2013

Geographic Reach

9 countries

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

October 22, 2013

Completed

9 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed

2 months until next milestone

Study Start

First participant enrolled

December 16, 2013

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2014

Completed

Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

October 22, 2013

Last Update Submit

December 22, 2020

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (2)

NNC0195-0092 (somapacitan)

EXPERIMENTAL

Drug: somapacitan

Norditropin®

ACTIVE COMPARATOR

Drug: somatropin

Interventions

somapacitanDRUG

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.

Also known as: NNC0195-0092

NNC0195-0092 (somapacitan)

somatropinDRUG

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

Norditropin®

Eligibility Criteria

Age6 Years - 13 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

History or presence of malignancy
Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)

Contact the study team to confirm eligibility.