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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258777
• Other study ID #: CR016345
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2010
• Last updated: September 3, 2013
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2013
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• 400 mg golimumab or placebo
Single dose of 400 mg subcutaneously
• 200 mg golimumab or placebo
Single dose of 200 mg subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects		Week 12 (Day 78)	No
Primary	Determine the immune response of golimumab in Japanese and Caucasian Male subjects		Week 12 (Day 78)	No
Primary	Safety of golimumab in Japanese and Caucasian Male subjects		Week 12 (Day 78)	No
Primary	Tolerability of golimumab in Japanese and Caucasian Male subjects		Week 12 (Day 78)	No