Clinical trial NCT00822185: Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))
timeFrame: between dosing and 2-3 weeks after dosing
measure: Subjects With Anti-Vatreptacog Alfa Antibody
timeFrame: between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing
Secondary outcomes:
measure: Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity- Terminal Slope (λz)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity- Total Clearance (CL)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)
timeFrame: during 1-2 days after drug administration
measure: Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)
timeFrame: during 1-2 days after drug administration
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: