Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects - Full Text View

Purpose

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

ChemIDplus related topics:

Etanercept

U.S. FDA Resources

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

Further study details as provided by Wyeth:

Primary Outcome Measures:

etanercept levels in the blood [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of single doses of etanercept administered to healthy Chinese subjects [ Time Frame: 21 days ] [ Designated as safety issue: No ]

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

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705042

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Locations


China
		Recruiting
	Beijing, China, 100730
		Recruiting
	Beijing, China, 100853

China, Guangdong
		Recruiting
	Guangzhou, Guangdong, China, 510006

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A1-1110
First Received:	June 17, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00705042
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 September 23, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00705042