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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: 200 mg golimumab or placebo; Drug: 400 mg golimumab or placebo

• Registration Number: NCT01258777
• Lead Sponsor: Centocor, Inc.

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 response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Study Completion: 2011-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
001	200 mg golimumab or placebo	200 mg golimumab or placebo Single dose of 200 mg subcutaneously
002	400 mg golimumab or placebo	400 mg golimumab or placebo Single dose of 400 mg subcutaneously

Primary Outcome Measures

Name	Time	Method
Tolerability of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)
Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)
Determine the immune response of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)
Safety of golimumab in Japanese and Caucasian Male subjects	Week 12 (Day 78)