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A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects

NCT ID: NCT01258777

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.

Detailed Description

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This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg or 400 mg golimumab or placebo. Subjects 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 (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo.

Conditions

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Healthy Volunteers

Keywords

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Healthy volunteers Japanese male Caucasian male Simponi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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001

200 mg golimumab or placebo Single dose of 200 mg subcutaneously

Group Type EXPERIMENTAL

200 mg golimumab or placebo

Intervention Type DRUG

Single dose of 200 mg subcutaneously

002

400 mg golimumab or placebo Single dose of 400 mg subcutaneously

Group Type EXPERIMENTAL

400 mg golimumab or placebo

Intervention Type DRUG

Single dose of 400 mg subcutaneously

Interventions

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400 mg golimumab or placebo

Single dose of 400 mg subcutaneously

Intervention Type DRUG

200 mg golimumab or placebo

Single dose of 200 mg subcutaneously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have no clinically relevant abnormalities
* non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
* Japanese subjects born in Japan, outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents, determined by subject's verbal report
* Japanese subjects must have a valid Japanese passport
* Caucasian subjects must have Caucasian parents.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centocor, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

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Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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CR016345

Identifier Type: -

Identifier Source: org_study_id