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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01288157 |
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Date of registration:
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22/11/2010 |
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Primary sponsor: |
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Public title:
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A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects
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Scientific title:
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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 |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01288157 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Centocor, Inc. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centocor, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy Adult Chinese Males
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Intervention(s)
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Drug: Golimumab
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Immunogenicity of golimumab, as measured by antibodies to golimumab
[Time Frame: Day 71]
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Number of participants with adverse events
[Time Frame: Day 71]
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Secondary ID(s)
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C0524T30
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CR016273
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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