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

Phase 1

Completed

• Conditions: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass; Healthy
• Interventions: Drug: placebo; Drug: catridecacog

• Registration Number: NCT01153997
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	placebo	-
D	placebo	-
B	catridecacog	-
A	catridecacog	-

Primary Outcome Measures

Name	Time	Method
Occurrence of serious adverse events	from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing
Occurrence of non-serious adverse events	from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing

Secondary Outcome Measures

Name	Time	Method
AUC (area under the curve) from time zero to 28 days	at day 28