NCT00822185CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 32
- Primary Endpoint
- Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
vatreptacog alfa, 5 mcg/kg
Experimental
Intervention: vatreptacog alfa (activated) (Drug)
vatreptacog alfa, 30 mcg/kg
Experimental
Intervention: vatreptacog alfa (activated) (Drug)
vatreptacog alfa, 5 mcg/kg
Experimental
Intervention: placebo (Drug)
vatreptacog alfa, 10 mcg/kg
Experimental
Intervention: vatreptacog alfa (activated) (Drug)
vatreptacog alfa, 10 mcg/kg
Experimental
Intervention: placebo (Drug)
vatreptacog alfa, 20 mcg/kg
Experimental
Intervention: vatreptacog alfa (activated) (Drug)
vatreptacog alfa, 20 mcg/kg
Experimental
Intervention: placebo (Drug)
vatreptacog alfa, 30 mcg/kg
Experimental
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)(during 1-2 days after drug administration)
- 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)
- 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)
- 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)
- 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)
Investigators
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