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

Withdrawn before enrolling · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01221636

Run by

Bristol-Myers Squibb

People needed

0

Starts

2010-10-01

Expected to finish

2011-02-01

Last updated by the study team

2015-09-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Austin, Texas, United States

Full record on ClinicalTrials.gov

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