NCT00705042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 28, 2009

Status Verified

July 1, 2009

Enrollment Period

2 months

First QC Date

June 17, 2008

Last Update Submit

July 27, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • etanercept levels in the blood

    21 days

Secondary Outcomes (1)

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

    21 days

Study Arms (2)

A

EXPERIMENTAL

25 mg

Drug: Etanercept

B

EXPERIMENTAL

50 mg

Drug: Etanercept

Interventions

EtanerceptDRUG
AB

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Guangzhou, Guangdong, 510006, China

Location

Unknown Facility

Beijing, 100730, China

Location

Unknown Facility

Beijing, 100853, China

Location

MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 25, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

July 28, 2009

Record last verified: 2009-07

Locations

CN(3)