Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept
| Status: | Withdrawn |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | October 2010 |
| End Date: | February 2011 |
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
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.
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.
following a single intravenous infusion of 750 mg in healthy subjects.
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
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