Status:
COMPLETED
A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers
Lead Sponsor:
Centocor, Inc.
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and how the body affects the drug CNTO 136 in healthy Japanese and Caucasian volunteers.
Detailed Description
This is a randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of CNTO 136. In a randomized trial, study medication (CNTO 136 or placebo) is assigned by chanc...
Eligibility Criteria
Inclusion
- Demonstrate an understanding of the study and sign an informed consent form
- Healthy with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count (CBC), coagulation tests, urinalysis, measurement of vital signs, and ECG
- Japanese volunteers must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents. Caucasian subjects must have Caucasian parents
- Have a weight in the range of 60 kg to 90 kg (inclusive), body mass index (BMI) of 19 kg/m2 to 29 kg/m2
- Nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.
Exclusion
- Currently have, or have a history of, disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system, that is clinically significant in the opinion of the investigator
- Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the healthy volunteer will complete the study
- Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
- Currently have any known malignancy or have a history of malignancy
- Have had major or traumatic surgery within 12 weeks of screening or any surgery within 1 week.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00844909
Start Date
January 1 2009
End Date
August 1 2009
Last Update
April 27 2010
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