A bioequivalence trial of Liquid 7 and NovoSeven in healthy volunteers
Research type
Research Study
Full title
A single centre, randomised, double-blind, two-way crossover trial in healthy male subjects investigating the bioequivalence of eptacog alfaA 2 mg and NovoSeven®
IRAS ID
142201
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2013-003163-63
ISRCTN Number
n/a
Research summary
NovoSeven® is the only recombinant by-passing agent globally available for treatment and prevention of bleeds in patients with haemophilia and inhibitors, including treatment during surgical procedures. NovoSeven has a well-established efficacy and safety profile, and has repeatedly proven to be efficacious in clinical trials during on-demand treatment of mild/moderate bleeds on a level of about 90% both with the 90 µg/kg x 3 and the 270 µg/kg x 1 dosage regimen.
NovoSeven® is a freeze dried formulation of rFVIIa, and must be reconstituted before administration. Liquid 7 (eptacog alfa A 6 mg; hereinafter referred to as Liquid 7) is a liquid formulation of rFVIIa. A liquid formulation will result in fewer handling steps prior to administration and may reduce the injection time.
The clinical development of Liquid 7 is based on comparability with the currently marketed NovoSeven®. The primary purpose of the clinical trial is to establish bioequivalence of Liquid 7 and NovoSeven®. The bioequivalence evaluation will be based on Cmax and AUC0-t of the plasma activity. Half-life (t½), clearance (CL), and other pharmacokinetic (PK) parameters will also be assessed. The single–dose administration and the suggested PK assessments are considered sufficient to allow for evaluation of bioequivalence.
The randomised, double-blinded crossover trial design is chosen to avoid bias in the evaluation, and is in alignment with current European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines for bioequivalence trials. The treatment will be intravenous (i.v.) as NovoSeven® is approved for intravenous injection only, and the same will apply for Liquid 7. The dose of 90 µg/kg is the NovoSeven® dose approved globally for treatment of a bleeding episode in patients with haemophilia and inhibitors, and this dose has also previously been administered to healthy participants without any safety concerns.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0082
Date of REC Opinion
27 Jan 2014
REC opinion
Favourable Opinion