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

Phase 1

Withdrawn

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept

• Registration Number: NCT01221636
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Status Verified: 2011-01
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Metal Abatacept	Abatacept	Reference
High Metal Abatacept	Abatacept	-

Primary Outcome Measures

Name	Time	Method
Single-dose pharmacokinetic parameters: AUC 0-71 days (Area under the serum concentration-time curve from time zero to 71 days)	Over 71 days after single dose administered
Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration)	Over 71 days after single dose administered
Single-dose pharmacokinetic parameters: AUC (INF) (Area under the serum concentration-time curve from time zero extrapolated to infinity)	Over 71 days after single dose administered

Secondary Outcome Measures

Name	Time	Method
Immunogenicity determination will be based on titers of anti abatacept and anti-CTLA-4-T antibodies in serum over time	Days 29, 57, and 71 after single dose administered
Safety assessments: adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance	Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71 after single dose administration

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Austin, Texas, United States