A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

Sponsor

Centocor, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01288157

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Chinese Males	Drug: Golimumab Drug: Golimumab	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label Study to Evaluate the Pharmacokinetics of a Single Subcutaneous Administration of 50 mg or 100 mg Golimumab in a Pre-filled Syringe Formulation to Healthy Male Chinese Subjects

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 Golimumab Single dose of 50 mg subcutaneously	Drug: Golimumab Single dose of 50 mg subcutaneously
Experimental: 002 Golimumab Single dose of 100 mg subcutaneously	Drug: Golimumab Single dose of 100 mg subcutaneously

Arm

Intervention/Treatment

Experimental: 001

Golimumab Single dose of 50 mg subcutaneously

Drug: Golimumab

Single dose of 50 mg subcutaneously

Experimental: 002

Golimumab Single dose of 100 mg subcutaneously

Drug: Golimumab

Single dose of 100 mg subcutaneously

Outcome Measures

Primary Outcome Measures

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

Number of participants with adverse events [Day 71]
Immunogenicity of golimumab, as measured by antibodies to golimumab [Day 71]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.