A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects

Launched by CENTOCOR, INC. · Dec 10, 2010

Keywords

ClinConnect Summary

This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Have no clinically relevant abnormalities
• • non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
• • Japanese subjects born in Japan, outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents, determined by subject's verbal report
• • Japanese subjects must have a valid Japanese passport
• • Caucasian subjects must have Caucasian parents.
• Exclusion Criteria:
• • Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
• • Have any underlying physical or psychological medical condition
• • Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.