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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass 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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A

Group Type EXPERIMENTAL

catridecacog

Intervention Type DRUG

Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

B

Group Type EXPERIMENTAL

catridecacog

Intervention Type DRUG

Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

C

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

D

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Interventions

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catridecacog

Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Intervention Type DRUG

placebo

Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Intervention Type DRUG

catridecacog

Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Intervention Type DRUG

placebo

Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes