drugset / Trial / NCT01416363

Healthy Volunteer Study Using 3 Different Formulations of Firategrast

NCT01416363 ↗

Phase 1 Completed 38 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2011-05-20
Primary completion
2011-09-17
Completion
2011-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Firategrast Small molecule 600 mg Oral
Subject Firategrast Small molecule 1200 mg Oral