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

NCT01153997 | Completed Phase 1

• 3 other identifiers: NN1810-3733U1111-1114-8989101192
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass; Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• AUC (area under the curve) from time zero to 28 days

  at day 28

Study Arms (4)

A

EXPERIMENTAL

Drug: catridecacog

B

EXPERIMENTAL

Drug: catridecacog

C

PLACEBO COMPARATOR

Drug: placebo

D

PLACEBO COMPARATOR

Drug: placebo

Interventions

catridecacog DRUG

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

A

placebo DRUG

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

C

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Fukuoka, 812-0025, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

JP (1)