Study Evaluating Etanercept 25mg or 50mg Administered Sub... | NCT00502879

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

NCT00502879

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Dec 6, 2007Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Healthy

Interventions

Enbrel (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

Dec 2007

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 2007

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Jul 16, 2007

First Submission Date that Met QC Criteria

Jul 17, 2007

First Posted Date

Jul 18, 2007Estimated

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

Dec 4, 2007

Last Update Posted Date

Dec 6, 2007Estimated

Description Module

Brief Summary

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.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Enbrel (etanercept)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the pharmacokinetics of etanercept in healthy Chinese male subjects.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

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
Trial Manager	For China: medinfo@wyeth.com	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing		100730	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