A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

May 26, 2014 updated by: Centocor, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Day 71 (Week 11)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Day 71
Day 71
Immunogenicity of golimumab, as measured by antibodies to golimumab
Time Frame: Day 71
Day 71

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centocor, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016273
  • C0524T30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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