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

NCT01221636 | Withdrawn Phase 1

• 1 other identifier: IM101-278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration)

  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)

  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)

  Over 71 days after single dose administered

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Low Metal Abatacept

OTHER

Reference

Drug: Abatacept

High Metal Abatacept

EXPERIMENTAL

Drug: Abatacept

Interventions

Abatacept DRUG

Solution for injection, Intravenous, 750 mg, 1 day

Also known as: Orencia, BMS-188667

High Metal Abatacept; Low Metal Abatacept

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Austin, Texas, 78744, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 15, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 1, 2015

Record last verified: 2011-01

Locations

US (1)