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Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept

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ClinicalTrials.gov Identifier: NCT01221636
Recruitment Status : Withdrawn
First Posted : October 15, 2010
Last Update Posted : September 1, 2015
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to determine whether the blood levels of abatacept drug product manufactured using High Metals and using Low Metals are comparable in healthy subjects.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Abatacept Phase 1

Detailed Description:
Compare the pharmacokinetic (PK) of High Metals abatacept relative to Low Metals abatacept following a single intravenous infusion of 750 mg in healthy subjects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Study to Compare the Pharmacokinetics of Abatacept (BMS-188667) Drug Product Using Active Pharmaceutical Ingredient Manufactured With a High Concentration of Metals Relative to the Active Pharmaceutical Ingredient Manufactured With a Low Concentration of Metals
Study Start Date : October 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arms and Interventions
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Arm Intervention/treatment
Low Metal Abatacept
Reference
 Drug: Abatacept
Solution for injection, Intravenous, 750 mg, 1 day
Other Names:
  • Orencia
  • BMS-188667
Experimental: High Metal Abatacept Drug: Abatacept
Solution for injection, Intravenous, 750 mg, 1 day
Other Names:
  • Orencia
  • BMS-188667


Outcome Measures
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Primary Outcome Measures :
  1. Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration) [ Time Frame: Over 71 days after single dose administered ]
  2. Single-dose pharmacokinetic parameters: AUC 0-71 days (Area under the serum concentration-time curve from time zero to 71 days) [ Time Frame: Over 71 days after single dose administered ]
  3. Single-dose pharmacokinetic parameters: AUC (INF) (Area under the serum concentration-time curve from time zero extrapolated to infinity) [ Time Frame: Over 71 days after single dose administered ]

Secondary Outcome Measures :
  1. Immunogenicity determination will be based on titers of anti abatacept and anti-CTLA-4-T antibodies in serum over time [ Time Frame: Days 29, 57, and 71 after single dose administered ]
  2. Safety assessments: adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance [ Time Frame: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71 after single dose administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, 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 HIV-1, -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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221636


Locations
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United States, Texas
Local Institution
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
Investigator Inquiry form  This link exits the ClinicalTrials.gov site

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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01221636     History of Changes
Other Study ID Numbers: IM101-278
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: January 2011
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Immunosuppressive Agents
Physiological Effects of Drugs
Antirheumatic Agents
Arthritis
Arthritis, Rheumatoid
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors