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
2 other identifiers
interventional
24
1 country
1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 2, 2011
CompletedMay 28, 2014
May 1, 2014
4 months
November 22, 2010
May 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects
Day 71 (Week 11)
Secondary Outcomes (2)
Number of participants with adverse events
Day 71
Immunogenicity of golimumab, as measured by antibodies to golimumab
Day 71
Study Arms (2)
001
EXPERIMENTALGolimumab Single dose of 50 mg subcutaneously
002
EXPERIMENTALGolimumab Single dose of 100 mg subcutaneously
Interventions
Eligibility Criteria
You may qualify if:
- Have no clinically relevant abnormalities
- non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (1)
Unknown Facility
Beijing, China
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2010
First Posted
February 2, 2011
Study Start
September 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
May 28, 2014
Record last verified: 2014-05