A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01288157
First received: November 22, 2010
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Healthy Adult Chinese Males
Drug: Golimumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Day 71 ] [ Designated as safety issue: No ]
  • Immunogenicity of golimumab, as measured by antibodies to golimumab [ Time Frame: Day 71 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288157

Locations
China
Beijing, China
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01288157     History of Changes
Other Study ID Numbers: CR016273, C0524T30
Study First Received: November 22, 2010
Last Updated: May 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
healthy
adult
Chinese
male
Simponi
CNTO 148

ClinicalTrials.gov processed this record on August 26, 2014