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

January 13, 2009
June 10, 2013
January 2009
July 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00822185 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Mode of Action 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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Healthy
  • 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
  • Experimental: A
    Interventions:
    • Drug: vatreptacog alfa (activated)
    • Drug: placebo
  • Experimental: B
    Interventions:
    • Drug: vatreptacog alfa (activated)
    • Drug: placebo
  • Experimental: C
    Interventions:
    • Drug: vatreptacog alfa (activated)
    • Drug: placebo
  • Experimental: D
    Interventions:
    • Drug: vatreptacog alfa (activated)
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00822185
NN1731-3604, JapicCTI-090681
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tomio Sasaki, BSc Novo Nordisk Pharma Ltd.
Novo Nordisk A/S
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP