Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00502879

Purpose

The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy Chinese male subjects. Safety and tolerability data will also be obtained.

Condition	Intervention	Phase
Healthy	Drug: Enbrel (etanercept)	Phase I

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	A Randomized, Open-Label, Single-Dose Administration, Parallel-Group Study of the Pharmacokinetics of Etanercept, 25mg or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess the pharmacokinetics of etanercept in healthy Chinese male subjects.

Study Start Date:	July 2007
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Men, aged 18 to 45 years, of Chinese descent and living in China.
Body mass index in the range of 18.0 to 30.0 kg/meter squared and body weight equal to or greater than 50 kg.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray, and 12-lead electrocardiogram (ECG).
Have a high probability for compliance with and completion of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502879

Locations

China

Beijing, China, 100730

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For China: medinfo@wyeth.com

More Information

Study ID Numbers:	0881A1-1109
Study First Received:	July 16, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00502879
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Healthy
TNFR-Fc fusion protein

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009