drugset / Trial / NCT01424462

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

NCT01424462 ↗

Phase 1 Completed 20 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2010-04-19
Primary completion
2010-07-06
Completion
2010-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Firategrast Small molecule — Oral