Dose Response and Efficacy of GW842166 in Pain

February 12, 2015 updated by: GlaxoSmithKline

A Phase I, Placebo Controlled, Randomised, Double Blind Two-way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments.

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.

Study Overview

Status

Withdrawn

Conditions

Healthy Subjects

Intervention / Treatment

Drug: GW842166X

Study Type

Interventional

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Heat pain threshold at 5 hours post dose Time Frame: 5 Hours	5 Hours

Secondary Outcome Measures

Outcome Measure	Time Frame
• Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose. Time Frame: 5 Hours	5 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ANTICIPATED)

March 1, 2008

Study Completion (ANTICIPATED)

March 1, 2008

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria