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

Phase 1 Completed 56 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start: 2007-08
Primary completion: 2008-01
Completion: 2008-01

Publications

Results Rasmussen MH, Bysted BV, Anderson TW, Klitgaard T, Madsen J. Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile. J Clin Endocrinol Metab. 2010 Jul;95(7):3411-7. doi: 10.1210/jc.2009-2813. Epub 2010 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Norditropin SimpleXx	Unknown	0.02 mg/kg	Subcutaneous
Comparator	Norditropin SimpleXx	Unknown	0.04 mg/kg	Subcutaneous
Subject	SOMATROPIN PEGOL	Protein / enzyme biologic	—	Subcutaneous

Indications

No indication recorded.