A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

Sponsor: Centocor, Inc.
Study ID: NCT01288157
Phase: PHASE1
Status: Completed

Conditions

Healthy Adult Chinese Males

Eligibility Criteria

Sex: MALE
Age: 18 Years - 45 Years
Healthy Volunteers: Accepted

Interventions

Golimumab — DRUG
Single dose of 100 mg subcutaneously
Golimumab — DRUG
Single dose of 50 mg subcutaneously

Study Details

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.

Key Dates

Start date: Sep 30, 2010
Status verified: May 2014
Primary completion: Jan 31, 2011
Completion: Jan 31, 2011

Study Design

Enrollment: 24 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: 001
Golimumab Single dose of 50 mg subcutaneously
Experimental: 002
Golimumab Single dose of 100 mg subcutaneously

Primary Outcome Measure

Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects [ Time Frame: Day 71 (Week 11) ]