A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Growth Hormone DisorderGrowth Hormone Deficiency in Children
Interventions
DRUG

NNC126-0083

One single dose administered in four dose levels in an escalating order

DRUG

somatropin

A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant

Trial Locations (21)

1000

Novo Nordisk Investigational Site, Skopje

1090

Novo Nordisk Investigational Site, Brussels

1525

Novo Nordisk Investigational Site, Ljubljana

8000

Novo Nordisk Investigational Site, Århus C

9000

Novo Nordisk Investigational Site, Ghent

15018

Novo Nordisk Investigational Site, Prague

15706

Novo Nordisk Investigational Site, Santiago de Compostela

31059

Novo Nordisk Investigational Site, Toulouse

34093

Novo Nordisk Investigational Site, Istanbul

44281

Novo Nordisk Investigational Site, Kfar Saba

49202

Novo Nordisk Investigational Site, Petah Tikva

69677

Novo Nordisk Investigational Site, Bron

84101

Novo Nordisk Investigational Site, Beersheba

91240

Novo Nordisk Investigational Site, Jerusalem

08035

Novo Nordisk Investigational Site, Barcelona

08950

Novo Nordisk Investigational Site, Esplugues Llobregat

01009

Novo Nordisk Investigational Site, Vitoria-Gasteiz

06100

Novo Nordisk Investigational Site, Ankara

Unknown

Novo Nordisk Investigational Site, Ankara

B4 6NH

Novo Nordisk Investigational Site, Birmingham

CB2 2QQ

Novo Nordisk Investigational Site, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00936403 - A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone | Biotech Hunter | Biotech Hunter