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

NCT01272206 | Completed Phase 1

• 3 other identifiers: NN7128-37292010-021286-67U1111-1118-0208
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events (AEs)

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

Secondary Outcomes (1)

• Neutralising antibodies against FVII and/or N7-GP

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

Study Arms (2)

A

EXPERIMENTAL

Drug: NNC 0128-0000-2011

B

EXPERIMENTAL

Drug: NNC 0128-0000-2021

Interventions

NNC 0128-0000-2011 DRUG

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

A

NNC 0128-0000-2021 DRUG

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

B

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Manchester, M15 6SH, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 7, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

GB (1)