Safety, Tolerability and Mode of Action of NN1731 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00822185
First received: January 13, 2009
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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 mode of action (pharmacokinetics) of NN1731 will be examined.


Condition Intervention Phase
Congenital Bleeding Disorder
Healthy
Drug: vatreptacog alfa (activated)
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Safety (physical examination, vital signs, ECG, haematology, biochemistry, urinalysis, coagulation factors, coagulation-related parameters, injection site tolerability and AE) [ Time Frame: between dosing and 2-3 weeks after dosing ] [ Designated as safety issue: Yes ]
  • Anti-NN1731 antibody [ Time Frame: between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • NN1731 clot activity (AUC0-t, AUC0-24, AUC0-inf, Cmax, C5min, C0, terminal slope, t1/2, CL, Vss, Vc and MRT) [ Time Frame: during 1-2 days after drug administration ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Experimental: B Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
Experimental: C Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
Experimental: D 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: 30 mcg/kg

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese male subjects, who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data
  • BMI between 18.0 and 27.0 kg/m2

Exclusion Criteria:

  • Any clinically laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG findings at the screening , as judged by the Investigator or Sub-investigator
  • Presence or History of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric diseases or disorders.
  • Evidence of clinically relevant pathology or a potential thromboembolic risk as judged by the Investigator or Sub-investigator
  • Presence or history of atherosclerosis, arteriosclerosis or thromboembolic events
  • Any past history of migraine
  • Overt bleeding, including from the gastrointestinal tract
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822185

Locations
Japan
Tokyo, Japan, 130-0004
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tomio Sasaki, BSc Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00822185     History of Changes
Other Study ID Numbers: NN1731-3604, JapicCTI-090681
Study First Received: January 13, 2009
Last Updated: June 10, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014