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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153997
• Other study ID #: NN1810-3733
• Secondary ID: U1111-1114-89891
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2010
• Last updated: June 17, 2014
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labour and Welfare (MHLW)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Cardiac Surgery Requiring Cardiopulmonary Bypass
• Healthy
• Hemostatic Disorders

Intervention

Drug:
• catridecacog
Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
• placebo
Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
• catridecacog
Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
• placebo
Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of serious adverse events		from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing	Yes
Primary	Occurrence of non-serious adverse events		from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing	Yes
Secondary	AUC (area under the curve) from time zero to 28 days		at day 28	No

External Links

•   Clinical Trials at Novo Nordisk