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

Rheumatoid Arthritis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01221636
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Withdrawn
Phase Phase 1
Start date October 2010
Completion date February 2011
View Details
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