Study Evaluating Enbrel Drug Levels in Healthy Male Chine... | NCT00705042

Studies
Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

NCT00705042

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Jul 28, 2009Estimated

Enrollment

60Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

Etanercept

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jun 17, 2008

First Submission Date that Met QC Criteria

Jun 23, 2008

First Posted Date

Jun 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2009

Last Update Posted Date

Jul 28, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	25 mg	Drug: Etanercept
B	Experimental	50 mg	Drug: Etanercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug		A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
etanercept levels in the blood		21 days

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability of single doses of etanercept administered to healthy Chinese subjects		21 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Guangzhou	Guangdong	510006	China

Intervention Browse Module

MeSH Terms

ID	Term
D000068800	Etanercept

Ancestor Terms

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided