Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.

• Status: Completed
• Trial end date: 2010-07-06
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate how 3 new 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 involves all volunteers receiving all 3 different formulations, as a single dose, and 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 as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.

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

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Male or female, aged 18 to 65 yrs inclusive

• Healthy, as determined by study physician

• Capable of giving informed 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 21 units for males, more than 14 units for females)

• Participation in a clinical trial within 90 days of scheduled first dose