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

Bristol-Myers Squibb

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Conditions

Rheumatoid Arthritis

Interventions

AbataceptDRUG

Solution for injection, Intravenous, 750 mg, 1 day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Austin, Texas, United States

Outcomes

Primary Outcomes

Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration)

Time frame: 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)

Time frame: 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)

Time frame: Over 71 days after single dose administered

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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