A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

This study has been completed.

Sponsor:

Information provided by:

Centocor, Inc.

ClinicalTrials.gov Identifier:

NCT01081704

First received: February 25, 2010

Last updated: July 8, 2010

Last verified: July 2010

History of Changes

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:

Drug Information available for: Ustekinumab

U.S. FDA Resources

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

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

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

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

No publications provided

Responsible Party:	Senior Director, Centocor
ClinicalTrials.gov Identifier:	NCT01081704 History of Changes
Other Study ID Numbers:	CR016207
Study First Received:	February 25, 2010
Last Updated:	July 8, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Centocor, Inc.:

Healthy volunteer
Chinese male
Stelara

Additional relevant MeSH terms:

Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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