Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

Wyeth is now a wholly owned subsidiary of Pfizer60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

EtanerceptDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Guangzhou, Guangdong, China

Unnamed facility

Beijing, China

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

etanercept levels in the blood

Time frame: 21 days

Secondary Outcomes

Safety and tolerability of single doses of etanercept administered to healthy Chinese subjects

Time frame: 21 days

Data from ClinicalTrials.gov

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