Safety, Tolerability and Pharmacokinetics 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: September 22, 2014
Last verified: September 2014
Results First Received: September 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Congenital Bleeding Disorder
Healthy
Interventions: Drug: vatreptacog alfa (activated)
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted at a single site in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vatreptacog Alfa 5 mcg/kg A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
Vatreptacog Alfa 10 mcg/kg A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
Vatreptacog Alfa 20 mcg/kg A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
Vatreptacog Alfa 30 mcg/kg A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
Placebo A single dose of placebo was administered intravenously

Participant Flow:   Overall Study
    Vatreptacog Alfa 5 mcg/kg     Vatreptacog Alfa 10 mcg/kg     Vatreptacog Alfa 20 mcg/kg     Vatreptacog Alfa 30 mcg/kg     Placebo  
STARTED     6     6     6     6     8  
COMPLETED     6     6     6     6     8  
NOT COMPLETED     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vatreptacog Alfa 5 mcg/kg A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
Vatreptacog Alfa 10 mcg/kg A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
Vatreptacog Alfa 20 mcg/kg A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
Vatreptacog Alfa 30 mcg/kg A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
Placebo A single dose of placebo was administered intravenously
Total Total of all reporting groups

Baseline Measures
    Vatreptacog Alfa 5 mcg/kg     Vatreptacog Alfa 10 mcg/kg     Vatreptacog Alfa 20 mcg/kg     Vatreptacog Alfa 30 mcg/kg     Placebo     Total  
Number of Participants  
[units: participants]
  6     6     6     6     8     32  
Age  
[units: years]
Mean ± Standard Deviation
  28.8  ± 6.5     23.3  ± 3.4     26.5  ± 3.5     26.3  ± 5.1     26.5  ± 7.7     26.3  ± 5.6  
Gender  
[units: participants]
           
Female     0     0     0     0     0     0  
Male     6     6     6     6     8     32  



  Outcome Measures
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1.  Primary:   Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))   [ Time Frame: between dosing and 2-3 weeks after dosing ]

2.  Primary:   Subjects With Anti-Vatreptacog Alfa Antibody   [ Time Frame: between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing ]

3.  Secondary:   Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)   [ Time Frame: during 1-2 days after drug administration ]

4.  Secondary:   Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)   [ Time Frame: during 1-2 days after drug administration ]

5.  Secondary:   Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)   [ Time Frame: during 1-2 days after drug administration ]

6.  Secondary:   Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)   [ Time Frame: during 1-2 days after drug administration ]

7.  Secondary:   Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)   [ Time Frame: during 1-2 days after drug administration ]

8.  Secondary:   Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)   [ Time Frame: during 1-2 days after drug administration ]

9.  Secondary:   Vatreptacog Alfa Clot Activity- Terminal Slope (λz)   [ Time Frame: during 1-2 days after drug administration ]

10.  Secondary:   Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)   [ Time Frame: during 1-2 days after drug administration ]

11.  Secondary:   Vatreptacog Alfa Clot Activity- Total Clearance (CL)   [ Time Frame: during 1-2 days after drug administration ]

12.  Secondary:   Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)   [ Time Frame: during 1-2 days after drug administration ]

13.  Secondary:   Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)   [ Time Frame: during 1-2 days after drug administration ]

14.  Secondary:   Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)   [ Time Frame: during 1-2 days after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


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
Results First Received: September 27, 2013
Last Updated: September 22, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare