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

Centocor Ortho Biotech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: 200 mg golimumab or placebo

Drug: 400 mg golimumab or placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01258777

CR016345

Details and patient eligibility

About

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

Full 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.

Enrollment

49 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.