Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090681 | Registry Identifier | JAPIC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vatreptacog alfa, 5 mcg/kg | Experimental |
| |
| vatreptacog alfa, 10 mcg/kg | Experimental |
| |
| vatreptacog alfa, 20 mcg/kg | Experimental |
| |
| vatreptacog alfa, 30 mcg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vatreptacog alfa (activated) | Drug | One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg |
|
| 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)) | Any safety issue was reported as AE | 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 | between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing |
| 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) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | 130-0004 | Japan |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
This trial was conducted at a single site in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vatreptacog Alfa 5 mcg/kg | A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously |
| FG001 | Vatreptacog Alfa 10 mcg/kg | A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously |
| FG002 | Vatreptacog Alfa 20 mcg/kg | A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously |
| FG003 | Vatreptacog Alfa 30 mcg/kg | A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously |
| FG004 | Placebo | A single dose of placebo was administered intravenously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vatreptacog Alfa 5 mcg/kg | A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously |
| BG001 | Vatreptacog Alfa 10 mcg/kg | A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Safety analysis set included all the randomised subjects who received at least one dose of the trial product. | Posted | Number | number of events | between dosing and 2-3 weeks after dosing |
|
After dosing adverse events were collected for approximately 11-13 weeks.
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vatreptacog Alfa 5 mcg/kg | A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
Not provided
| ID | Term |
|---|---|
| C000596433 | vatreptacog alfa |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| placebo | Drug | Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg |
|
| placebo | Drug | Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg |
|
| placebo | Drug | Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg |
|
| placebo | Drug | Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg |
|
| 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. |
| 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. | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax) | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min) | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity- Terminal Slope (λz) | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2) | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity- Total Clearance (CL) | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss) | during 1-2 days after drug administration |
| Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD) | 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 | during 1-2 days after drug administration |
| BG002 | Vatreptacog Alfa 20 mcg/kg | A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously |
| BG003 | Vatreptacog Alfa 30 mcg/kg | A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously |
| BG004 | Placebo | A single dose of placebo was administered intravenously |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Vatreptacog Alfa 20 mcg/kg | A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously |
| OG003 | Vatreptacog Alfa 30 mcg/kg | A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously |
| OG004 | Placebo | A single dose of placebo was administered intravenously |
|
|
| Primary | Subjects With Anti-Vatreptacog Alfa Antibody | Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody | Safety analysis set included all the randomised subjects who received at least one dose of the trial product. | Posted | Number | participants | between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing |
|
|
|
| Secondary | 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. | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | (IU*h)/mL | during 1-2 days after drug administration |
|
|
|
| Secondary | 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. | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | (IU*h)/mL | during 1-2 days after drug administration |
|
|
|
| Secondary | 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. | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | (IU*h)/mL | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/mL | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/mL | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/mL | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity- Terminal Slope (λz) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity- Total Clearance (CL) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subjects did not contribute to data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h/kg | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subject did not contribute to PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/kg | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD) | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/kg | during 1-2 days after drug administration |
|
|
|
| Secondary | Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT) | Mean residence time of the unchanged drug in the systemic circulation | PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | during 1-2 days after drug administration |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Vatreptacog Alfa 10 mcg/kg | A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously | 0 | 6 | 0 | 6 |
| EG002 | Vatreptacog Alfa 20 mcg/kg | A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously | 0 | 6 | 0 | 6 |
| EG003 | Vatreptacog Alfa 30 mcg/kg | A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously | 0 | 6 | 0 | 6 |
| EG004 | Placebo | A single dose of placebo was administered intravenously | 0 | 8 | 0 | 8 |
Novo Nordisk reserves the right to defer data release until specified milestones, e.g. availability of a clinical trial report. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property. Novo Nordisk reserves the right to prior review of site-specific publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.