Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

December 12, 2014 updated by: Novo Nordisk A/S

A Single-centre, Randomised, Placebo-controlled, Double-blind, Single-dose, Dose-escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Doses of an Activated Recombinant FVII Analogue (NN1731) in Healthy Japanese Male Subjects

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 130-0004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Japanese male subjects, who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator or Sub-investigator
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (inclusive)

Exclusion Criteria:

  • Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the Investigator or Sub-investigator
  • Presence or history of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
  • Evidence of clinically relevant pathology or a potential thromboembolic risk as judged by the Investigator or Sub-investigator
  • Presence or history of atherosclerosis, arteriosclerosis or thromboembolic events
  • Any past history of migraine
  • Overt bleeding, including from the gastrointestinal tract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: vatreptacog alfa, 5 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
Experimental: vatreptacog alfa, 10 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
Experimental: vatreptacog alfa, 20 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
Experimental: vatreptacog alfa, 30 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
Drug: vatreptacog alfa (activated)
One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
Drug: placebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))
Time Frame: between dosing and 2-3 weeks after dosing
Any safety issue was reported as AE
between dosing and 2-3 weeks after dosing
Subjects With Anti-Vatreptacog Alfa Antibody
Time Frame: between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing
Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody
between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)
Time Frame: during 1-2 days after drug administration
AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)
Time Frame: during 1-2 days after drug administration
Blood samples were collected at following time points: -30 min, -20 min, -10 min, 5 min, 10 min, 20 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 8h, 12h and 24h to calculate area under the curve.
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)
Time Frame: during 1-2 days after drug administration
AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Terminal Slope (λz)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Total Clearance (CL)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)
Time Frame: during 1-2 days after drug administration
during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)
Time Frame: during 1-2 days after drug administration
Mean residence time of the unchanged drug in the systemic circulation
during 1-2 days after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN1731-3604
  • JapicCTI-090681 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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