Status:
COMPLETED
Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
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 (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are compar...
Detailed Description
Primary Purpose of this study is to compare the pharmacokinetic (PK) of Abatacept (BMS-188667) manufactured at Lonza relative to Abatacept (BMS-188667) manufactured at Devens, MA facility following a ...
Eligibility Criteria
Inclusion
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (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 Human Immunodeficiency Virus-1, Human Immunodeficiency Virus-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 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01439204
Start Date
October 1 2011
End Date
February 1 2012
Last Update
March 19 2014
Active Locations (1)
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1
Icon Clinical Pharmacology Unit, Llc
Omaha, Nebraska, United States, 68154