A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01081704
First received: February 25, 2010
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

A study of the pharmacokinetics of ustekinumab in Chinese male subjects.


Condition Intervention Phase
Healthy
Drug: ustekinumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Immune response (immunogenicity) of ustekinumab [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081704

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

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01081704     History of Changes
Other Study ID Numbers: CR016207
Study First Received: February 25, 2010
Last Updated: May 26, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014