NCT01153997

Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers

A Randomised, Placebo-controlled Single-dose, Parallel-group, Double-blind Trial Evaluating Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.

Conditions

• Acquired Bleeding Disorder
• Cardiac Surgery Requiring Cardiopulmonary Bypass
• Healthy

Interventions

Type	Name	Description
DRUG	catridecacog	Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
DRUG	placebo	Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
DRUG	catridecacog	Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
DRUG	placebo	Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-06-30
• Last updated: 2014-06-18

Locations

1 site across 1 country: Japan