Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding

PHASE1TerminatedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
HaemostasisHealthy
Interventions
DRUG

eptacog alfa (activated)

If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies

DRUG

clopidogrel

Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).

DRUG

placebo

If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies

Trial Locations (1)

07753

Novo Nordisk Investigational Site, Neptune City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY