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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
• Interventions: Drug: NNC 0128-0000-2011; Drug: NNC 0128-0000-2021

• Registration Number: NCT01272206
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	NNC 0128-0000-2011	-
B	NNC 0128-0000-2021	-

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs)	from first trial product administration until maximally 10 weeks after last trial product administration

Secondary Outcome Measures

Name	Time	Method
Neutralising antibodies against FVII and/or N7-GP	from first trial product administration until maximally 10 weeks after last trial product administration