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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

NNC 0128-0000-2011

NNC 0128-0000-2021

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - 49 Years (Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Frequency of adverse events (AEs)

Secondary Outcome Measures

Neutralising antibodies against FVII and/or N7-GP

Full Information

NCT ID

NCT01272206

First Posted

January 6, 2011

Last Updated

August 19, 2014

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01272206

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

NNC 0128-0000-2011

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NNC 0128-0000-2021

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of adverse events (AEs)

Time Frame

from first trial product administration until maximally 10 weeks after last trial product administration

Secondary Outcome Measure Information:

Title

Neutralising antibodies against FVII and/or N7-GP

Time Frame

from first trial product administration until maximally 10 weeks after last trial product administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

City

Manchester

ZIP/Postal Code

M15 6SH

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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