Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Congenital Bleeding Disorder

Treatments: Drug: placebo; Drug: vatreptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822185

JapicCTI-090681 (Registry Identifier)

NN1731-3604

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups

vatreptacog alfa, 5 mcg/kg

Experimental group

Treatment:

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: vatreptacog alfa (activated)

vatreptacog alfa, 10 mcg/kg

Experimental group

Treatment:

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: vatreptacog alfa (activated)

vatreptacog alfa, 20 mcg/kg

Experimental group

Treatment:

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: vatreptacog alfa (activated)

vatreptacog alfa, 30 mcg/kg

Experimental group

Treatment:

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: vatreptacog alfa (activated)

Drug: placebo

Drug: placebo

Drug: placebo

Drug: placebo

Drug: vatreptacog alfa (activated)