Congenital Bleeding Disorder, Healthy
Conditions
Brief 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
Interventions
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
DRUGplacebo
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) | between dosing and 2-3 weeks after dosing | Any safety issue was reported as AE |
| Subjects With Anti-Vatreptacog Alfa Antibody | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t) | 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. |
| Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24) | 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. |
| Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf) | 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. |
| 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- Initial Volume of Distribution (VD) | 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- Mean Residence Time (MRT) | during 1-2 days after drug administration | Mean residence time of the unchanged drug in the systemic circulation |
| Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) | 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 | — |
Countries
Japan
Participant flow
Recruitment details
This trial was conducted at a single site in Japan.
Participants by arm
| Arm | Count |
|---|---|
| Vatreptacog Alfa 5 mcg/kg A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously | 6 |
| Vatreptacog Alfa 10 mcg/kg A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously | 6 |
| Vatreptacog Alfa 20 mcg/kg A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously | 6 |
| Vatreptacog Alfa 30 mcg/kg A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously | 6 |
| Placebo A single dose of placebo was administered intravenously | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa 30 mcg/kg | Placebo |
|---|---|---|---|---|---|---|
| Age, Continuous | 26.3 years STANDARD_DEVIATION 5.6 | 28.8 years STANDARD_DEVIATION 6.5 | 23.3 years STANDARD_DEVIATION 3.4 | 26.5 years STANDARD_DEVIATION 3.5 | 26.3 years STANDARD_DEVIATION 5.1 | 26.5 years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 |
Outcome results
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
Time frame: between dosing and 2-3 weeks after dosing
Population: Safety analysis set included all the randomised subjects who received at least one dose of the trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) | 0 number of events |
| Vatreptacog Alfa 10 mcg/kg | Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) | 0 number of events |
| Vatreptacog Alfa 20 mcg/kg | Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) | 0 number of events |
| Vatreptacog Alfa 30 mcg/kg | Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) | 0 number of events |
| Placebo | Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) | 0 number of events |
Primary
Subjects With Anti-Vatreptacog Alfa Antibody
Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody
Time frame: between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing
Population: Safety analysis set included all the randomised subjects who received at least one dose of the trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Subjects With Anti-Vatreptacog Alfa Antibody | 0 participants |
| Vatreptacog Alfa 10 mcg/kg | Subjects With Anti-Vatreptacog Alfa Antibody | 0 participants |
| Vatreptacog Alfa 20 mcg/kg | Subjects With Anti-Vatreptacog Alfa Antibody | 0 participants |
| Vatreptacog Alfa 30 mcg/kg | Subjects With Anti-Vatreptacog Alfa Antibody | 0 participants |
| Placebo | Subjects With Anti-Vatreptacog Alfa Antibody | 0 participants |
Secondary
Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)
Time frame: during 1-2 days after drug administration
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss) | 164.23 mL/kg | Geometric Coefficient of Variation 55 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss) | 131.72 mL/kg | Geometric Coefficient of Variation 15.4 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss) | 83.23 mL/kg | Geometric Coefficient of Variation 18.5 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss) | 79.67 mL/kg | Geometric Coefficient of Variation 9.8 |
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.
Time frame: during 1-2 days after drug administration
Population: PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t) | 7.875 (IU*h)/mL | Geometric Coefficient of Variation 10.7 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t) | 13.845 (IU*h)/mL | Geometric Coefficient of Variation 15 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t) | 30.268 (IU*h)/mL | Geometric Coefficient of Variation 7.5 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t) | 46.986 (IU*h)/mL | Geometric Coefficient of Variation 6.4 |
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.
Time frame: during 1-2 days after drug administration
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf) | 8.128 (IU*h)/mL | Geometric Coefficient of Variation 14.7 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf) | 13.195 (IU*h)/mL | Geometric Coefficient of Variation 8.1 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf) | 30.351 (IU*h)/mL | Geometric Coefficient of Variation 7.7 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf) | 47.060 (IU*h)/mL | Geometric Coefficient of Variation 6.4 |
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.
Time frame: during 1-2 days after drug administration
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24) | 7.970 (IU*h)/mL | Geometric Coefficient of Variation 11.8 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24) | 13.143 (IU*h)/mL | Geometric Coefficient of Variation 8.1 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24) | 30.310 (IU*h)/mL | Geometric Coefficient of Variation 7.5 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24) | 47.021 (IU*h)/mL | Geometric Coefficient of Variation 6.3 |
Secondary
Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)
Time frame: during 1-2 days after drug administration
Population: PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) | 19.802 IU/mL | Geometric Coefficient of Variation 8.4 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) | 34.497 IU/mL | Geometric Coefficient of Variation 14.2 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) | 69.474 IU/mL | Geometric Coefficient of Variation 7.3 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) | 106.916 IU/mL | Geometric Coefficient of Variation 5.5 |
Secondary
Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)
Time frame: during 1-2 days after drug administration
Population: PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min) | 15.767 IU/mL | Geometric Coefficient of Variation 10.4 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min) | 27.569 IU/mL | Geometric Coefficient of Variation 13.9 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min) | 55.732 IU/mL | Geometric Coefficient of Variation 5.9 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min) | 86.974 IU/mL | Geometric Coefficient of Variation 4.4 |
Secondary
Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)
Time frame: during 1-2 days after drug administration
Population: PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD) | 43.15 mL/kg | Geometric Coefficient of Variation 10.5 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD) | 49.31 mL/kg | Geometric Coefficient of Variation 15.2 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD) | 48.41 mL/kg | Geometric Coefficient of Variation 5.8 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD) | 47.67 mL/kg | Geometric Coefficient of Variation 4.9 |
Secondary
Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)
Time frame: during 1-2 days after drug administration
Population: PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax) | 15.767 IU/mL | Geometric Coefficient of Variation 10.4 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax) | 27.569 IU/mL | Geometric Coefficient of Variation 13.9 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax) | 55.732 IU/mL | Geometric Coefficient of Variation 5.9 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax) | 86.974 IU/mL | Geometric Coefficient of Variation 4.4 |
Secondary
Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)
Mean residence time of the unchanged drug in the systemic circulation
Time frame: during 1-2 days after drug administration
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT) | 1.56 hours | Geometric Coefficient of Variation 73 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT) | 1.02 hours | Geometric Coefficient of Variation 14.5 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT) | 0.75 hours | Geometric Coefficient of Variation 20.5 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT) | 0.74 hours | Geometric Coefficient of Variation 13 |
Secondary
Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)
Time frame: during 1-2 days after drug administration
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2) | 7.51 hours | Geometric Coefficient of Variation 59 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2) | 4.90 hours | Geometric Coefficient of Variation 32.1 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2) | 3.14 hours | Geometric Coefficient of Variation 49.9 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2) | 3.07 hours | Geometric Coefficient of Variation 53.5 |
Secondary
Vatreptacog Alfa Clot Activity- Terminal Slope (λz)
Time frame: during 1-2 days after drug administration
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity- Terminal Slope (λz) | 0.09 1/h | Geometric Coefficient of Variation 59 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity- Terminal Slope (λz) | 0.14 1/h | Geometric Coefficient of Variation 32.1 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity- Terminal Slope (λz) | 0.22 1/h | Geometric Coefficient of Variation 49.9 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity- Terminal Slope (λz) | 0.23 1/h | Geometric Coefficient of Variation 53.5 |
Secondary
Vatreptacog Alfa Clot Activity- Total Clearance (CL)
Time frame: during 1-2 days after drug administration
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vatreptacog Alfa 5 mcg/kg | Vatreptacog Alfa Clot Activity- Total Clearance (CL) | 105.14 mL/h/kg | Geometric Coefficient of Variation 16.5 |
| Vatreptacog Alfa 10 mcg/kg | Vatreptacog Alfa Clot Activity- Total Clearance (CL) | 129.56 mL/h/kg | Geometric Coefficient of Variation 6.3 |
| Vatreptacog Alfa 20 mcg/kg | Vatreptacog Alfa Clot Activity- Total Clearance (CL) | 110.82 mL/h/kg | Geometric Coefficient of Variation 6.6 |
| Vatreptacog Alfa 30 mcg/kg | Vatreptacog Alfa Clot Activity- Total Clearance (CL) | 108.30 mL/h/kg | Geometric Coefficient of Variation 6.2 |