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A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

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ClinicalTrials.gov Identifier: NCT01288157
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):

November 22, 2010
February 2, 2011
May 28, 2014
September 2010
January 2011   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT01288157 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: Day 71 ]
  • Immunogenicity of golimumab, as measured by antibodies to golimumab [ Time Frame: Day 71 ]
Same as current
Not Provided
Not Provided
 
A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Adult Chinese Males
  • Drug: Golimumab
    Single dose of 100 mg subcutaneously
  • Drug: Golimumab
    Single dose of 50 mg subcutaneously
  • Experimental: 001
    Golimumab Single dose of 50 mg subcutaneously
    Intervention: Drug: Golimumab
  • Experimental: 002
    Golimumab Single dose of 100 mg subcutaneously
    Intervention: Drug: Golimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2011
January 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01288157
CR016273
C0524T30
Not Provided
Not Provided
Not Provided
Centocor, Inc.
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP