Clinical trial NCT01258777: A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Japanese male
Caucasian male
Simponi
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-13
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Pharmacokinetics (study of what the body does to the drug) of golimumab in Japanese and Caucasian Male subjects
timeFrame: Week 12 (Day 78)
measure: Determine the immune response of golimumab in Japanese and Caucasian Male subjects
timeFrame: Week 12 (Day 78)
measure: Safety of golimumab in Japanese and Caucasian Male subjects
timeFrame: Week 12 (Day 78)
measure: Tolerability of golimumab in Japanese and Caucasian Male subjects
timeFrame: Week 12 (Day 78)
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: