World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 September 2015
Main ID:  NCT01221636
Date of registration: 13/10/2010
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept
Scientific 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
Date of first enrolment: October 2010
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT01221636
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
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]
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: Cmax (Maximum observed serum concentration) [Time Frame: Over 71 days after single dose administered]
Secondary Outcome(s)
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]
Secondary ID(s)
IM101-278
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history