Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Cardiac Surgery Requiring Cardiopulmonary Bypass

Acquired Bleeding Disorder

Treatments

Drug: placebo

Drug: catridecacog

Study type

Interventional

Funder types

Industry

Identifiers

NCT01153997

101192 (Registry Identifier)

U1111-1114-8989 (Other Identifier)

NN1810-3733

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.

Enrollment

24 patients

Sex

Male

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram) and clinical laboratory data at screening, as judged by the physician
Body mass index (BMI) between 18.0-27.0 kg/m2 (both inclusive)

Exclusion criteria

The receipt of any investigational products for coagulation factor protein within 6 months prior to trial start (screening)
Known or suspected allergy to yeast
Known bleeding or hematologic disorder
Significant history of alcoholism or drug/chemical abuse as judged by the physician or positive result in the alcohol breath test/screen of drugs at the trial start (screening)
Smoking more than 10 cigarettes/day or equivalent
Not able or willing to refrain from smoking whenever required for the trial procedures
Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the physician
Excessive consumption of a diet deviating from a normal diet as judged by the physician
Strenuous exercise as judged by the physician within 4 days prior to trial start (screening)
Surgery or trauma with significant blood loss (500 mL or more blood) within 3 months prior to trial start (screening)
Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods. Adequate contraceptive measures include that the subject uses a condom during intercourse or that the partner practices adequate conception (sterilisation, hormonal intrauterine devices and oral contraceptives).