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

Sponsor

Centocor, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01258777

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: 400 mg golimumab or placebo Drug: 200 mg golimumab or placebo	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CNTO 148 Following Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects

Study Start Date :

Oct 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 200 mg golimumab or placebo Single dose of 200 mg subcutaneously	Drug: 200 mg golimumab or placebo Single dose of 200 mg subcutaneously
Experimental: 002 400 mg golimumab or placebo Single dose of 400 mg subcutaneously	Drug: 400 mg golimumab or placebo Single dose of 400 mg subcutaneously

Arm

Intervention/Treatment

Experimental: 001

200 mg golimumab or placebo Single dose of 200 mg subcutaneously

Drug: 200 mg golimumab or placebo

Single dose of 200 mg subcutaneously

Experimental: 002

400 mg golimumab or placebo Single dose of 400 mg subcutaneously

Drug: 400 mg golimumab or placebo

Single dose of 400 mg subcutaneously

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects [Week 12 (Day 78)]
Determine the immune response of golimumab in Japanese and Caucasian Male subjects [Week 12 (Day 78)]
Safety of golimumab in Japanese and Caucasian Male subjects [Week 12 (Day 78)]
Tolerability of golimumab in Japanese and Caucasian Male subjects [Week 12 (Day 78)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.