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

Congenital Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272206
• Other study ID #: NN7128-3729
• Secondary ID: 2010-021286-67U1
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2011
• Last updated: August 19, 2014
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: August 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• NNC 0128-0000-2011
Administered as one single i.v. (intravenous) injection, 100 mcg/kg
• NNC 0128-0000-2021
Administered as one single i.v. (intravenous) injection, 100 mcg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events (AEs)		from first trial product administration until maximally 10 weeks after last trial product administration	No
Secondary	Neutralising antibodies against FVII and/or N7-GP		from first trial product administration until maximally 10 weeks after last trial product administration	No

External Links

•   Clinical Trials at Novo Nordisk