Status:
COMPLETED
A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects
Lead Sponsor:
Centocor, Inc.
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.
Detailed Description
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 res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01258777
Start Date
October 1 2010
End Date
April 1 2011
Last Update
September 4 2013
Active Locations (1)
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1
Cypress, California, United States