Dose Response and Efficacy of GW842166 in Pain

Healthy Subjects Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00554762
• Other study ID #: CBA110877
• Status: Withdrawn
• Phase: Phase 1
• First received: November 5, 2007
• Last updated: February 12, 2015
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: February 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• GW842166X
Administer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Heat pain threshold at 5 hours post dose		5 Hours
Secondary	• Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose.		5 Hours