Status:
WITHDRAWN
Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01221636
Start Date
October 1 2010
End Date
February 1 2011
Last Update
September 1 2015
Active Locations (1)
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1
Local Institution
Austin, Texas, United States, 78744