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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Abatacept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low Metal Abatacept<br>Reference | Drug: Abatacept<br>* Solution for injection, Intravenous, 750 mg, 1 day<br>* Other names: BMS-188667;|
| Experimental: High Metal Abatacept<br> | Drug: Abatacept<br>* Solution for injection, Intravenous, 750 mg, 1 day<br>* Other names: BMS-188667;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration) |  | Over 71 days after single dose administered | 
| Single-dose pharmacokinetic parameters: AUC 0-71 days (Area under the serum concentration-time curve from time zero to 71 days) |  | Over 71 days after single dose administered | 
| Single-dose pharmacokinetic parameters: AUC (INF) (Area under the serum concentration-time curve from time zero extrapolated to infinity) |  | Over 71 days after single dose administered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity determination will be based on titers of anti abatacept and anti-CTLA-4-T antibodies in serum over time |  | Days 29, 57, and 71 after single dose administered | 
| 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 |  | Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71 after single dose administration |