NCT01272206

Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects

A Single-centre, Randomised, Double-blind, Single Dose, Cross-over Trial Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021, Following Intravenous Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B

Interventions

Type	Name	Description
DRUG	NNC 0128-0000-2011	Administered as one single i.v. (intravenous) injection, 100 mcg/kg
DRUG	NNC 0128-0000-2021	Administered as one single i.v. (intravenous) injection, 100 mcg/kg

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-01-07
• Last updated: 2014-08-20

Locations

1 site across 1 country: United Kingdom