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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
Unnamed facility
Tokyo, Japan
Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))
Any safety issue was reported as AE
Time frame: between dosing and 2-3 weeks after dosing
Subjects With Anti-Vatreptacog Alfa Antibody
Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody
Time frame: between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing
Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)
AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)
Blood samples were collected at following time points: -30 min, -20 min, -10 min, 5 min, 10 min, 20 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 8h, 12h and 24h to calculate area under the curve.
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)
AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)
Time frame: during 1-2 days after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Terminal Slope (λz)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Total Clearance (CL)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)
Mean residence time of the unchanged drug in the systemic circulation
Time frame: during 1-2 days after drug administration