Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Healthy Japanese Male Volunteers

NCT00421226 | Completed Phase 1

• 1 other identifier: CACZ885A1101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese male volunteers.

Conditions

Healthy

Keywords

Safety, tolerability, pharmacokinetics, pharmacodynamics, ACZ885, Japanese,

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

Secondary Outcomes (1)

• Pharmacokinetics and pharmacodynamics

Interventions

ACZ885 DRUG

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese healthy male subjects age 20 to 45 years of age, and in good health
• At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
• Body mass index within the range of 18 to 28 kg/m2 and weigh 50 to 100 kg

You may not qualify if:

• Smokers.
• Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable. Treatment of any biologics within three months prior to dosing. Having live vaccinations within six months prior to dosing.
• Participation in any clinical investigation within 4 months prior to dosing.
• Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to participation.
• Significant illness (sinusitis, pneumonia, cystitis, sepsis, etc) within two weeks prior to dosing.
• A past personal or close family medical history of cardiac disorders
• History of:
• fainting,
• low blood pressure when standing,
• abnormal heart rhythms
• acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
• Clinically significant drug allergy or history and complication of atopic allergy (asthma, urticaria, eczematous dermatitis)
• Known hypersensitivity to the study drug or similar drugs
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or jeopardize participation in the study.
• History of immunodeficiency diseases, including a positive HIV test result.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative site

Tokyo, Japan

Location

MeSH Terms

Interventions

canakinumab

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

JP (1)