- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081704
A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects
May 26, 2014 updated by: Centocor, Inc.
A Study to Evaluate the Pharmacokinetics of Ustekinumab Following a Single Subcutaneous Administration of 45 mg or 90 mg to Healthy, Chinese, Male Subjects
A study of the pharmacokinetics of ustekinumab in Chinese male subjects.
Study Overview
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 ustekinumab (Stelara).
The study population will consist of 24 healthy male participants in China.
Participants will receive a single dose of either 45mg or 90 mg ustekinumab.
Participants will be in the study for up to 16 weeks.
Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events.
A single dose of 45 mg or 90 mg ustekinumab.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Have no clinically relevant abnormalities
- Non smoker
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
ustekinumab Single dose of 45 mg subcutaneous injection
|
Single dose of 45 mg subcutaneous injection
Single dose of 90 mg subcutaneous injection
|
Experimental: 002
ustekinumab Single dose of 90 mg subcutaneous injection
|
Single dose of 45 mg subcutaneous injection
Single dose of 90 mg subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.
Time Frame: Week 16
|
Week 16
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events
Time Frame: Week 16
|
Week 16
|
Immune response (immunogenicity) of ustekinumab
Time Frame: Week 16
|
Week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
February 25, 2010
First Submitted That Met QC Criteria
March 4, 2010
First Posted (Estimate)
March 5, 2010
Study Record Updates
Last Update Posted (Estimate)
May 28, 2014
Last Update Submitted That Met QC Criteria
May 26, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR016207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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