NCT01034202

Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®

A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers

Conditions

• Growth Hormone Disorder
• Healthy

Interventions

Type	Name	Description
DRUG	NNC126-0083	One of five dose levels administered subcutaneously (under the skin)
DRUG	Norditropin® SimpleXx®	One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
DRUG	placebo	Placebo comparator
DRUG	NNC126-0083	One of three dose levels administered subcutaneously (under the skin)
DRUG	Norditropin® SimpleXx®	One of two dose levels, followed by placebo, administered subcutaneously (under the skin)

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2009-12-17
• Last updated: 2017-02-09

Locations

1 site across 1 country: Denmark