Congenital Bleeding DisorderPhase 1NCT00822185
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers
A Phase 1 study testing vatreptacog alfa (activated) in people with Congenital Bleeding Disorder and Healthy, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Healthy
- What is being tested?
- vatreptacog alfa (activated)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2009to Jul 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Congenital Bleeding Disorder, Healthy
- Being tested
- vatreptacog alfa (activated), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vatreptacog alfa (activated)Drug
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
vatreptacog alfa (activated)Drug
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
vatreptacog alfa (activated)Drug
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
vatreptacog alfa (activated)Drug
One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
placeboDrug
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
placeboDrug
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
placeboDrug
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
placeboDrug
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| vatreptacog alfa, 5 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated); Drug: placebo |
| vatreptacog alfa, 10 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated); Drug: placebo |
| vatreptacog alfa, 20 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated); Drug: placebo |
| vatreptacog alfa, 30 mcg/kg | Experimental | Not described Receives: Drug: vatreptacog alfa (activated); Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))
Any safety issue was reported as AE
Measured: between dosing and 2-3 weeks after dosing
Subjects With Anti-Vatreptacog Alfa Antibody
Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody
Measured: between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing
Secondary outcomes (12)
Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)
AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.
Measured: 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)
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.
Measured: 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)
AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Terminal Slope (λz)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Total Clearance (CL)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)
Measured: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)
Mean residence time of the unchanged drug in the systemic circulation
Measured: during 1-2 days after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822185
- Sponsor's protocol ID
- NN1731-3604
- Other IDs
- JapicCTI-090681
- Status last verified
- Dec 2014
- First submitted
- 13 Jan 2009
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00822185
- Acronym / sponsor ID
- NN1731-3604
- Conditions
- Congenital Bleeding Disorder, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Posted 23 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vatreptacog alfa, 5 mcg/kg | Experimental | Drug: vatreptacog alfa (activated), Drug: placebo |
| vatreptacog alfa, 10 mcg/kg | Experimental | Drug: vatreptacog alfa (activated), Drug: placebo |
| vatreptacog alfa, 20 mcg/kg | Experimental | Drug: vatreptacog alfa (activated), Drug: placebo |
| vatreptacog alfa, 30 mcg/kg | Experimental | Drug: vatreptacog alfa (activated), Drug: placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vatreptacog alfa (activated)One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg | Drug | vatreptacog alfa, 5 mcg/kg |
| vatreptacog alfa (activated)One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg | Drug | vatreptacog alfa, 10 mcg/kg |
| vatreptacog alfa (activated)One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg | Drug | vatreptacog alfa, 20 mcg/kg |
| vatreptacog alfa (activated)One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg | Drug | vatreptacog alfa, 30 mcg/kg |
| placeboSingle dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg | Drug | vatreptacog alfa, 5 mcg/kg |
| placeboSingle dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg | Drug | vatreptacog alfa, 10 mcg/kg |
| placeboSingle dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg | Drug | vatreptacog alfa, 20 mcg/kg |
| placeboSingle dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg | Drug | vatreptacog alfa, 30 mcg/kg |
Primary outcome
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
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
12 secondary outcomes
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
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
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
Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)
Time frame: 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
Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Terminal Slope (λz)
Time frame: 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
Vatreptacog Alfa Clot Activity- Total Clearance (CL)
Time frame: 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
Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)
Time frame: during 1-2 days after drug administration
Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)
Time frame: during 1-2 days after drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vatreptacog alfa (activated) in people with Congenital Bleeding Disorder and Healthy, run by Novo Nordisk A/S at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.