A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

Phase 1

Completed

• Conditions: Healthy Adult Chinese Males
• Interventions: Drug: Golimumab

• Registration Number: NCT01288157
• Lead Sponsor: Centocor, Inc.

Brief Summary

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

Detailed Description

This is a randomized (study medication assigned by chance), open-label (both the physician and subject 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 participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 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 50 mg or 100 mg golimumab as a subcutaneous injection.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-22
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-26
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

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	Golimumab	Golimumab Single dose of 50 mg subcutaneously
002	Golimumab	Golimumab Single dose of 100 mg subcutaneously

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Day 71
Immunogenicity of golimumab, as measured by antibodies to golimumab	Day 71