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Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

NCT00822185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-01-05

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Japan

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00822185 on ClinicalTrials.gov