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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01221636
First received: October 13, 2010
Last updated: January 13, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Abatacept
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration) [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameters: AUC 0-71 days (Area under the serum concentration-time curve from time zero to 71 days) [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]
  • Single-dose pharmacokinetic parameters: AUC (INF) (Area under the serum concentration-time curve from time zero extrapolated to infinity) [ Time Frame: Over 71 days after single dose administered ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity determination will be based on titers of anti abatacept and anti-CTLA-4-T antibodies in serum over time [ Time Frame: Days 29, 57, and 71 after single dose administered ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71 after single dose administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: October 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low Metal Abatacept
Reference
Drug: Abatacept
Solution for injection, Intravenous, 750 mg, 1 day
Other Names:
  • Orencia
  • BMS-188667
Experimental: High Metal Abatacept Drug: Abatacept
Solution for injection, Intravenous, 750 mg, 1 day
Other Names:
  • Orencia
  • BMS-188667

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221636

Locations
United States, Texas
Local Institution
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01221636     History of Changes
Other Study ID Numbers: IM101-278
Study First Received: October 13, 2010
Last Updated: January 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abatacept
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014