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A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

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ClinicalTrials.gov Identifier: NCT01081704
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

Brief Summary:
A study of the pharmacokinetics of ustekinumab in Chinese male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: ustekinumab Phase 1

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Pharmacokinetics of Ustekinumab Following a Single Subcutaneous Administration of 45 mg or 90 mg to Healthy, Chinese, Male Subjects
Study Start Date : October 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ustekinumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 001
ustekinumab Single dose of 45 mg subcutaneous injection
Drug: ustekinumab
Single dose of 45 mg subcutaneous injection
Experimental: 002
ustekinumab Single dose of 90 mg subcutaneous injection
Drug: ustekinumab
Single dose of 90 mg subcutaneous injection



Primary Outcome Measures :
  1. Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants. [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Immune response (immunogenicity) of ustekinumab [ Time Frame: Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081704


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01081704     History of Changes
Other Study ID Numbers: CR016207
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Centocor, Inc.:
Healthy volunteer
Chinese male
Stelara

Additional relevant MeSH terms:
Ustekinumab
Dermatologic Agents