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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01258777
First received: November 22, 2010
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects [ Time Frame: Week 12 (Day 78) ] [ Designated as safety issue: No ]
  • Determine the immune response of golimumab in Japanese and Caucasian Male subjects [ Time Frame: Week 12 (Day 78) ] [ Designated as safety issue: No ]
  • Safety of golimumab in Japanese and Caucasian Male subjects [ Time Frame: Week 12 (Day 78) ] [ Designated as safety issue: No ]
  • Tolerability of golimumab in Japanese and Caucasian Male subjects [ Time Frame: Week 12 (Day 78) ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: October 2010
Study Completion Date: April 2011
Arms Assigned Interventions
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

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258777

Locations
United States, California
Cypress, California, United States
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01258777     History of Changes
Other Study ID Numbers: CR016345
Study First Received: November 22, 2010
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Centocor, Inc.:
Healthy volunteers
Japanese male
Caucasian male
Simponi

ClinicalTrials.gov processed this record on September 18, 2014