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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies, Monoclonal; Golimumab

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.