NCT00554762

Brief Summary

The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_1

Status
withdrawn

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

Study Start

First participant enrolled

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

November 5, 2007

Last Update Submit

February 12, 2015

Conditions

Healthy Subjects

Keywords

mechanical pain,heat pain,dose,efficacydose response,GW842166,Single,pharmacodynamics,repeat dose,

Outcome Measures

Primary Outcomes (1)

  • • Heat pain threshold at 5 hours post dose

    5 Hours

Secondary Outcomes (1)

  • • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose.

    5 Hours

Interventions

GW842166XDRUG

Administer

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects aged 18 to 50 years inclusive
  • Body Weight \>50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
  • Women who are not of child bearing potential

You may not qualify if:

  • The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
  • A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
  • Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

2-((2,4-dichlorphenyl)amino)-N-((tetrahydro-2H-pyran-4-yl)methyl)-4-(trifluoromethyl)-5-pyrimidinecarboxamide

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 16, 2015

Record last verified: 2015-02