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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01153997
First received: June 29, 2010
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Healthy
Drug: catridecacog
Drug: placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Occurrence of serious adverse events [ Time Frame: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing ] [ Designated as safety issue: Yes ]
  • Occurrence of non-serious adverse events [ Time Frame: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUC (area under the curve) from time zero to 28 days [ Time Frame: at day 28 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: B 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: 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.
Placebo Comparator: D 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153997

Locations
Japan
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01153997     History of Changes
Other Study ID Numbers: NN1810-3733, U1111-1114-8989, 101192
Study First Received: June 29, 2010
Last Updated: June 17, 2014
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014