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Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00705042 |
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.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects |
Drug: Etanercept |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Open-Label, Single-Dose Administration, Parallel-Group, Multisite Study of the Pharmacokinetics of Etanercept, 25 or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
25 mg
|
Drug: Etanercept |
B: Experimental
50 mg
|
Drug: Etanercept |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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 Criteria:
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.
Contact: Trial Manager | clintrialparticipation@wyeth.com |
China | |
Recruiting | |
Beijing, China, 100730 | |
Recruiting | |
Beijing, China, 100853 | |
China, Guangdong | |
Recruiting | |
Guangzhou, Guangdong, China, 510006 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0881A1-1110 |
Study First Received: | June 17, 2008 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00705042 |
Health Authority: | China: State Food and Drug Administration |
Healthy TNFR-Fc fusion protein |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |