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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Compare the pharmacokinetic (PK) of High Metals abatacept relative to Low Metals abatacept following a single intravenous infusion of 750 mg in healthy subjects.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Low Metal Abatacept

Reference

Group Type OTHER

Abatacept

Intervention Type DRUG

Solution for injection, Intravenous, 750 mg, 1 day

High Metal Abatacept

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

Solution for injection, Intravenous, 750 mg, 1 day

Interventions

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Abatacept

Solution for injection, Intravenous, 750 mg, 1 day

Intervention Type DRUG

Other Intervention Names

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Orencia BMS-188667

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes