A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects

Centocor, Inc.24 enrolled

Overview

The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.

This is a randomized (study medication assigned by chance), open-label (both the physician and subject 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 participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 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 50 mg or 100 mg golimumab as a subcutaneous injection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Adult Chinese Males

Interventions

GolimumabDRUG

Single dose of 100 mg subcutaneously

GolimumabDRUG

Single dose of 50 mg subcutaneously

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Locations (1)

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects

Time frame: Day 71 (Week 11)

Secondary Outcomes

Number of participants with adverse events

Time frame: Day 71

Immunogenicity of golimumab, as measured by antibodies to golimumab

Time frame: Day 71

Data from ClinicalTrials.gov

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