Phase 1
Completed N=32
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers
Congenital Bleeding Disorder · Healthy
Source: ClinicalTrials.gov NCT00822185 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) — 0; 0; 0; 0 number of events
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE)) |
0; 0; 0; 0; 0 | — |
| PRIMARY Subjects With Anti-Vatreptacog Alfa Antibody |
0; 0; 0; 0; 0 | — |
| SECONDARY 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; 13.845; 30.268; 46.986 | — |
| SECONDARY Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24) |
7.970; 13.143; 30.310; 47.021 | — |
| SECONDARY Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf) |
8.128; 13.195; 30.351; 47.060 | — |
| SECONDARY Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax) |
15.767; 27.569; 55.732; 86.974 | — |
| SECONDARY Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min) |
15.767; 27.569; 55.732; 86.974 | — |
| SECONDARY Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0) |
19.802; 34.497; 69.474; 106.916 | — |
| SECONDARY Vatreptacog Alfa Clot Activity- Terminal Slope (λz) |
0.09; 0.14; 0.22; 0.23 | — |
| SECONDARY Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2) |
7.51; 4.90; 3.14; 3.07 | — |
| SECONDARY Vatreptacog Alfa Clot Activity- Total Clearance (CL) |
105.14; 129.56; 110.82; 108.30 | — |
| SECONDARY Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss) |
164.23; 131.72; 83.23; 79.67 | — |
| SECONDARY Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD) |
43.15; 49.31; 48.41; 47.67 | — |
| SECONDARY Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT) |
1.56; 1.02; 0.75; 0.74 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00822185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.