Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Congenital Bleeding Disorder Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vatreptacog alfa, 5 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

vatreptacog alfa, 10 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg

placebo

Intervention Type DRUG

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg

vatreptacog alfa, 20 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg

placebo

Intervention Type DRUG

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg

vatreptacog alfa, 30 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg

placebo

Intervention Type DRUG

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg

Interventions

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vatreptacog alfa (activated)

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

Intervention Type DRUG

vatreptacog alfa (activated)

One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg

Intervention Type DRUG

vatreptacog alfa (activated)

One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg

Intervention Type DRUG

vatreptacog alfa (activated)

One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg

Intervention Type DRUG

placebo

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

Intervention Type DRUG

placebo

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg

Intervention Type DRUG

placebo

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg

Intervention Type DRUG

placebo

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No