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OpenTrials
Completed

NCT Number: NCT00822185

Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

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

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Key information

Conditions

Congenital Bleeding Disorder Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, 130-0004, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vatreptacog alfa (activated)

Drug

One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg

Placebo

Drug

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg

Primary outcomes

  1. 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

  2. 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

  1. 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

    AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.

  2. 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

    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.

  3. 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

    AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.

  4. Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)

    Time frame: during 1-2 days after drug administration

  5. Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)

    Time frame: during 1-2 days after drug administration

  6. Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)

    Time frame: during 1-2 days after drug administration

  7. Vatreptacog Alfa Clot Activity- Terminal Slope (λz)

    Time frame: during 1-2 days after drug administration

  8. Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)

    Time frame: during 1-2 days after drug administration

  9. Vatreptacog Alfa Clot Activity- Total Clearance (CL)

    Time frame: during 1-2 days after drug administration

  10. Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)

    Time frame: during 1-2 days after drug administration

  11. Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)

    Time frame: during 1-2 days after drug administration

  12. Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)

    Time frame: during 1-2 days after drug administration

    Mean residence time of the unchanged drug in the systemic circulation

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2009
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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