Status:
COMPLETED
Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male Chinese subjects.
Eligibility Criteria
Inclusion
- Healthy male Chinese subjects, ages 18 to 45. BMI in the range of 18 to 30 kg/m2 and weight greater than or equal to 50 kg.
Exclusion
- Active tuberculosis (TB) or history of TB. Serious infection (associated with hospitalization and/or antibiotics) within 1 month before study drug administration.
- History of protein drug hypersensitivity.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00705042
Start Date
July 1 2008
End Date
November 1 2008
Last Update
July 28 2009
Active Locations (3)
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1
Guangzhou, Guangdong, China, 510006
2
Beijing, China, 100730
3
Beijing, China, 100853