Pharmacokinetics of NNC 0128-0000-2011 compared to NNC 0128-0000-2021

• Research type

  Research Study

• Full title

  A single-centre, randomised, double-blind, single dose, cross-over trial investigating safety and pharmacokinetics of NNC 0128-0000-2011 compared to NNC 0128-0000-2021, following intravenous administration in healthy male subjects

• IRAS ID

  63918

• Contact name

  Anthony Priestley

• Sponsor organisation

  Novo Nordisk

• Eudract number

  2010-021286-67

• ISRCTN Number

  N/A

• Research summary

  The aim of this study is to assess the safety and blood levels of a new drug called NNC 0128-0000-2011 and to compare it with NNC 0128-0000-2021.The trial products are being developed for the prevention of bleeding in people who have haemophilia. Humans normally produce “clotting factors” which stop them from bleeding too much when they are injured, but in people with haemophilia, some of these clotting factors are lacking. In haemophilia, serious bleeding can result from quite trivial accidents. Factor 7 (FVII), one such “clotting factor”, currently marketed as NovoSeven© has been altered (by the addition of a large molecular group (GP)) in order to prolong its effect. In addition to the additional molecular group, Novo Nordisk, the Sponsor Drug company, has stopped the use of any animal-derived material in the production of their new trial product, NNC 0128-0000-2021. SF, “serum-free”, means without animal material, and CP, “current process”, with animal material. This will be the first time that NNC 0128-0000-2021 is given to humans. This is a single centre, double-blind, randomised 2-way crossover study. Each subject will participate in a screening visit, two study visits and 2 follow -up visits.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC03/22

• Date of REC Opinion

  22 Nov 2010

• REC opinion

  Further Information Favourable Opinion