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

A Randomised, Placebo-controlled Single-dose, Parallel-group, Double-blind Trial Evaluating Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Japanese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass
• Intervention / Treatment: Drug: catridecacog; Drug: catridecacog; Drug: placebo; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: C	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.; 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.
Experimental: A	Drug: catridecacog; Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.; Drug: catridecacog; Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
Experimental: B	Drug: catridecacog; Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.; Drug: catridecacog; Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
Placebo Comparator: D	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
AUC (area under the curve) from time zero to 28 days	at day 28

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: NN1810-3733; U1111-1114-8989 (Other Identifier: WHO); 101192 (Registry Identifier: JAPIC)