Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Haemophilia B

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: NNC 0128-0000-2021

Drug: NNC 0128-0000-2011

Study type

Interventional

Funder types

Industry

Identifiers

NCT01272206

U1111-1118-0208 (Other Identifier)

2010-021286-67 (EudraCT Number)

NN7128-3729

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.

Enrollment

12 patients

Sex

Male

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body weight between 50.0 and 100.0 kg, both inclusive
Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive

Exclusion criteria

Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII
Any clinical sign or known history of atherosclerosis or thromboembolic events
Renal dysfunction
A subject considered at high risk of thromboembolic events
Overt bleeding, including from gastrointestinal tract
Hepatitis B or C infection
Human immunodeficiency virus (HIV) infection
Positive test for drugs of abuse or alcohol as well as a history of alcohol or drug abuse within the past 12 months
Smoking within 3 months prior to trial start
Unable to abstain from alcohol consumption during visits of trial product administration, visit 2 (0-28 days after screening) and visit 3 (2-4 weeks after visit 2)
Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator (trial physician)
Excessive consumption of a diet deviating from a normal diet
Blood donation within the last three months prior to screening
The receipt of any investigational product within 30 days of trial product administration
Participation in any other trial investigating a procoagulant within the last six months prior to screening
Strenuous exercise within four days prior trial start
Suffers from a life threatening disease
Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise).
Subjects at increased cardiovascular risk, including a strong family history of cardiovascular disease
Subjects with high fasting cholesterol at trial start