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

Status

Completed

Conditions

Intervention / Treatment

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

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
Drug: ustekinumab
Single dose of 45 mg subcutaneous injection
Drug: ustekinumab
Single dose of 90 mg subcutaneous injection
Experimental: 002
ustekinumab Single dose of 90 mg subcutaneous injection
Drug: ustekinumab
Single dose of 45 mg subcutaneous injection
Drug: ustekinumab
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

Centocor, Inc.

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.

General Publications

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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