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

Part of paid clinical trials in Cypress, California.

Sponsor
Centocor, Inc.
Study ID
NCT01258777
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 31, 2010
Status verified
Sep 2013
Completion
Apr 30, 2011

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    200 mg golimumab or placebo Single dose of 200 mg subcutaneously
  • Experimental: 002
    400 mg golimumab or placebo Single dose of 400 mg subcutaneously

Primary Outcome Measure

Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects [ Time Frame: Week 12 (Day 78) ]

Locations (1)

FacilityCityStateZIPSite coordinators
-CypressCalifornia--

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