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

September 3, 2013 updated by: Centocor, Inc.

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CNTO 148 Following Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

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
  • 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 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
200 mg golimumab or placebo Single dose of 200 mg subcutaneously
Drug: 200 mg golimumab or placebo
Single dose of 200 mg subcutaneously
Experimental: 002
400 mg golimumab or placebo Single dose of 400 mg subcutaneously
Drug: 400 mg golimumab or placebo
Single dose of 400 mg subcutaneously

What is the study measuring?

Primary Outcome Measures

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

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

October 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016345

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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