Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Etanercept

• Registration Number: NCT00705042
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 available

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Study Start: 2008-07
• Primary Completion: 2008-09
• Study Completion: 2008-11
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-27
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Etanercept	25 mg
B	Etanercept	50 mg

Primary Outcome Measures

Name	Time	Method
etanercept levels in the blood	21 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of single doses of etanercept administered to healthy Chinese subjects	21 days