Healthy Volunteer Study Using 3 Different Formulations of Firategrast

• Status: Completed
• Trial end date: 2011-09-17
• Target enrollment: 0
• Participant gender: Male

Summary

This study will investigate how 3 types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Male aged 18 to 65 yrs inclusive

• Healthy, as determined by study physician

• Capable of giving iformed consent

Exclusion Criteria:

• Positive drugs of abuse result

• Positive for HIV or Hepatitis B and/or C viruses

• History of alcohol consumption in excess of average recommended weekly intake (more than 12 units for males)

• Participation in a clinical trial within 30 days of scheduled first dose