This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Peoria, Illinois, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, United States
Plasma FVIII activity at 30 minutes(C30min)
Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose
Time frame: At 30 minutes post-dose
Area under the FVIII activity-time curve
Time frame: From 0 up to 72 hours after administration
Incremental recovery FVIII at 30 minutes (IR30min)
Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose
Time frame: At 30 minutes post-dose
Terminal half-life (t½) of FVIII
Time frame: From 0 up to 72 hours after administration
Clearance (CL) of FVIII
Time frame: From 0 up to 72 hours after administration
Apparent volume of distribution at steady state (Vss) of FVIII
Time frame: From 0 up to 72 hours after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novo Nordisk Investigational Site
Richmond, Virginia, United States
Novo Nordisk Investigational Site
Vienna, Austria
Novo Nordisk Investigational Site
Sofia, Bulgaria
Novo Nordisk Investigational Site
Bonn, Germany
Novo Nordisk Investigational Site
Hanover, Germany
Novo Nordisk Investigational Site
Belgrade, Serbia
Novo Nordisk Investigational Site
Madrid, Spain
...and 5 more locations