This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia
Novo Nordisk Investigational Site
London, United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom
Area under the curve
Time frame: Infusion, 48 hours
Incremental recovery
Time frame: Infusion, 30 minutes
In vivo t1/2
Time frame: Infusion, 48 hours
Total clearance (CL)
Time frame: Infusion, 48 hours
Maximal concentration (Cmax)
Time frame: 15 minutes after trial drug administration
Number of adverse events
Time frame: up to 48 hours after trial drug administration
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