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Trial record 12 of 136 for:    Drug | "Connective Tissue Disease" | "Abatacept"

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

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ClinicalTrials.gov Identifier: NCT01221636
Recruitment Status : Withdrawn
First Posted : October 15, 2010
Last Update Posted : September 1, 2015
Sponsor:
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 13, 2010
First Posted Date  ICMJE October 15, 2010
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
  • Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration) [ Time Frame: Over 71 days after single dose administered ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01221636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Abatacept
Solution for injection, Intravenous, 750 mg, 1 day
Other Names:
  • Orencia
  • BMS-188667
Study Arms  ICMJE
  • Low Metal Abatacept
    Reference
    Intervention: Drug: Abatacept
  • Experimental: High Metal Abatacept
    Intervention: Drug: Abatacept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2010)
70
Estimated Study Completion Date  ICMJE February 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01221636
Other Study ID Numbers  ICMJE IM101-278
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP