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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 16, 2013

Primary Completion Date

November 4, 2014

Study Completion Date

November 4, 2014

Conditions
Growth Hormone DisorderGrowth Hormone Deficiency in Children
Interventions
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.

Trial Locations (22)

1000

Novo Nordisk Investigational Site, Skopje

1090

Novo Nordisk Investigational Site, Brussels

1200

Novo Nordisk Investigational Site, Brussels

1211

Novo Nordisk Investigational Site, Geneva

1525

Novo Nordisk Investigational Site, Ljubljana

4020

Novo Nordisk Investigational Site, Linz

4031

Novo Nordisk Investigational Site, Basel

5021

Novo Nordisk Investigational Site, Bergen

8036

Novo Nordisk Investigational Site, Graz

15706

Novo Nordisk Investigational Site, Santiago de Compostela

31059

Novo Nordisk Investigational Site, Toulouse

31096

Novo Nordisk Investigational Site, Haifa

44281

Novo Nordisk Investigational Site, Kfar Saba

49202

Novo Nordisk Investigational Site, Petah Tikva

52621

Novo Nordisk Investigational Site, Tel Litwinsky

75015

Novo Nordisk Investigational Site, Paris

91240

Novo Nordisk Investigational Site, Jerusalem

A 1090

Novo Nordisk Investigational Site, Vienna

08035

Novo Nordisk Investigational Site, Barcelona

08950

Novo Nordisk Investigational Site, Esplugues Llobregat(Barcelona)

01009

Novo Nordisk Investigational Site, Vitoria-Gasteiz

141 86

Novo Nordisk Investigational Site, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY