Brief Title
Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects
Official 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
Brief Summary
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Frequency of adverse events (AEs)
Secondary Outcome
Neutralising antibodies against FVII and/or N7-GP
Condition
Congenital Bleeding Disorder
Intervention
NNC 0128-0000-2011
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
January 2011
Completion Date
March 2011
Primary Completion Date
March 2011
Eligibility Criteria
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
Gender
Male
Ages
18 Years - 49 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01272206
Organization ID
NN7128-3729
Secondary IDs
2010-021286-67
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
August 2014