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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00822185
First received: January 13, 2009
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  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) 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: activated recombinant human factor VII analogue
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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: activated recombinant human factor VII analogue
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
Other Name: NN1731
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Experimental: B Drug: activated recombinant human factor VII analogue
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: activated recombinant human factor VII analogue
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: activated recombinant human factor VII analogue
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822185

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00822185     History of Changes
Other Study ID Numbers: NN1731-3604, JapicCTI-090681
Study First Received: January 13, 2009
Last Updated: July 9, 2012
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 May 22, 2013