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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01221636
• Other study ID #: IM101-278
• Status: Withdrawn
• Phase: Phase 1
• First received: October 13, 2010
• Last updated: August 31, 2015
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: January 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept
Solution for injection, Intravenous, 750 mg, 1 day

Locations

Country	Name	City	State
United States	Local Institution	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration)		Over 71 days after single dose administered	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
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