This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
CP-675,206 15 mg/kg iv single dose on Day 1
CP-675,206 15 mg/kg iv single dose on Day 1
Research Site
Scottsdale, Arizona, United States
Research Site
Aurora, Colorado, United States
Research Site
Aventura, Florida, United States
Research Site
Miami Beach, Florida, United States
Pharmacokinetics: maximum plasma concentration of CP-675,206
Time frame: 1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve
Time frame: Time 0 to Day 85
Human-anti-human antibodies
Time frame: 1 year
Adverse events
Time frame: 1 year
Safety laboratory tests
Time frame: 1 year
Proportion of patients alive and free of disease at 1 year
Time frame: 1 year
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Research Site
Atlanta, Georgia, United States
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States