NCT00822185

Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

A Single-centre, Randomised, Placebo-controlled, Double-blind, Single-dose, Dose-escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Doses of an Activated Recombinant FVII Analogue (NN1731) in Healthy Japanese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined

Conditions

• Congenital Bleeding Disorder
• Healthy

Interventions

Type	Name	Description
DRUG	vatreptacog alfa (activated)	One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
DRUG	vatreptacog alfa (activated)	One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
DRUG	vatreptacog alfa (activated)	One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
DRUG	vatreptacog alfa (activated)	One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
DRUG	placebo	Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
DRUG	placebo	Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
DRUG	placebo	Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
DRUG	placebo	Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-01-14
• Last updated: 2015-01-05
• Results posted: 2014-09-23

Locations

1 site across 1 country: Japan