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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

NNC 0128-0000-2011

Intervention Type DRUG

Administered as one single i.v. (intravenous) injection, 100 mcg/kg

B

Group Type EXPERIMENTAL

NNC 0128-0000-2021

Intervention Type DRUG

Administered as one single i.v. (intravenous) injection, 100 mcg/kg

Interventions

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NNC 0128-0000-2011

Administered as one single i.v. (intravenous) injection, 100 mcg/kg

Intervention Type DRUG

NNC 0128-0000-2021

Administered as one single i.v. (intravenous) injection, 100 mcg/kg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No