A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ustekinumab

• Registration Number: NCT01081704
• Lead Sponsor: Centocor, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-26
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
001	ustekinumab	ustekinumab Single dose of 45 mg subcutaneous injection
002	ustekinumab	ustekinumab Single dose of 90 mg subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.	Week 16

Secondary Outcome Measures

Name	Time	Method
Immune response (immunogenicity) of ustekinumab	Week 16
Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events	Week 16