A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.

Official Title
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A Randomized, Open-Label, Parallel-Group, Single-dose, Relative Bioavailability Study of the Pharmacokinetics of Subcutaneous Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process J Relative to the Current Abatacept Drug Process F in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Biological: Abatacept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants, defined as having no clinically significant deviation from normal in medical history; physical examinations that would compromise the ability to participate, complete, and/or interpret the results of the study; 12-lead ECG; vital signs; and clinical laboratory results Body weight between 60 and 100 kilograms (kg) inclusive, based on weight at screening Participant must have a suitable injection site without tattoos, scarring, or other conditions in the upper, outer arm that could interfere with SC administration Exclusion Criteria: Present malignancy or previous malignancy within the last 5 years prior to screening At risk for tuberculosis Any chronic bacterial infection within the previous 12 weeks of dosing Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abatacept Treatment A<br> | Biological: Abatacept<br>* Specified dose on specified days<br>* Other names: BMS-188667;|
| Experimental: Abatacept Treatment B<br> | Biological: Abatacept<br>* Specified dose on specified days<br>* Other names: BMS-188667;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | Up to Day 71 | 
| Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T)) |  | Up to Day 71 | 
| Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF)) |  | Up to Day 71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to Month 12 | 
| Number of participants with clinical laboratory abnormalities |  | Up to Month 12 | 
| Number of participants with vital sign abnormalities |  | Up to Month 12 | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to Day 71 | 
| Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours)) |  | Up to Day 71 | 
| Serum concentration at 168 hours after dosing (C168) |  | Up to Day 71 | 
| Time of maximum observed serum concentration (Tmax) |  | Up to Day 71 | 
| Number of laboratory-reported positive responses of anti-abatacept antibodies |  | Up to Month 12 | 
| Number of laboratory-reported positive responses of anti-CTLA4-T antibodies |  | Up to Day 71 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abatacept, Orencia, Pharmacokinetics, Bioavailability, BMS-188667