A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288157
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
Centocor, Inc.

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 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 Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

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

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Day 71 ]
  2. Immunogenicity of golimumab, as measured by antibodies to golimumab [ Time Frame: Day 71 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01288157

Beijing, China
Sponsors and Collaborators
Centocor, Inc.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.

Responsible Party: Centocor, Inc. Identifier: NCT01288157     History of Changes
Other Study ID Numbers: CR016273
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Centocor, Inc.:
CNTO 148

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs