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Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, MA Facility of Bristol-Myers Squibb

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01439204
First received: September 21, 2011
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects


Condition Intervention Phase
Rheumatoid Arthritis
 Biological: Abatacept (BMS-188667)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, NH in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Abatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Single-dose pharmacokinetic parameter Maximum observed serum concentration (Cmax) of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameter Time to reach Cmax in serum (Tmax) of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from time zero to 28 days [AUC(0-28 days)] of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration [AUC(0-T)] of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(INF)] of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameter Terminal phase elimination half-life in serum (T-HALF) of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameter Total Body Clearance (CLT) of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameter Volume of distribution at steady-state (Vss) of Abatacept (BMS-188667) will be derived from serum concentration versus time data [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity determination will be based on titers of anti Abatacept and anti-CTLA-4-T antibodies in serum over time [ Time Frame: On Days 29, 57, and 71 after single dose administered ] [ Designated as safety issue: No ]
    CTLA-4 : Cytotoxic T-lymphocyte (T-cell)-associated antigen 4

  • Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests [ Time Frame: On Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71 after single dose administration ] [ Designated as safety issue: Yes ]
    The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance


Enrollment: 223
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Abatacept (BMS-188667) manufactured at Lonza, NH facility Biological: Abatacept (BMS-188667)
Solution for injection, Intravenous, 750 mg, Single dose, 1 day,
Other Name: BMS-188667
Experimental: Abatacept (BMS-188667) manufactured at Devens, MA facility Biological: Abatacept (BMS-188667)
Solution for injection, Intravenous, 750 mg, Single dose, 1 day,
Other Name: BMS-188667

Detailed Description:

Primary Purpose of this study is to compare the pharmacokinetic (PK) of Abatacept (BMS-188667) manufactured at Lonza relative to Abatacept (BMS-188667) manufactured at Devens, MA facility following a single intravenous infusion of 750 mg in healthy subjects

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
  • Body weight will be between 60 and 100 kg, inclusive

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Any major surgery within 4 weeks of study drug administration
  • Smoking more than 10 cigarettes per day
  • Recent (within 6 months of study drug administration) drug or alcohol abuse.
  • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody
  • History of any significant drug allergy or asthma
  • Women who are pregnant or breastfeeding and/or unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439204

Locations
United States, Nebraska
Icon Clinical Pharmacology Unit, Llc
Omaha, Nebraska, United States, 68154
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01439204     History of Changes
Other Study ID Numbers: IM101-292
Study First Received: September 21, 2011
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013