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

Bristol-Myers Squibb (BMS)

Status and phase

Withdrawn

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Abatacept

Study type

Interventional

Funder types

Industry

Identifiers

NCT01221636

IM101-278

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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