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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01258777

Run by

Centocor, Inc.

People needed

49

Starts

2010-10-01

Expected to finish

2011-04-01

Last updated by the study team

2013-09-04

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

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