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.
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.
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.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Healthy Subjects | |||
| Intervention ICMJE | Drug: Etanercept | |||
| Study Arms ICMJE |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 60 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | November 2008 | |||
| Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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. | |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 45 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00705042 | |||
| Other Study ID Numbers ICMJE | 0881A1-1110 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | July 2009 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
