drugset / Trial / NCT00427141

A Three-Part Study Of GSK580416 In Healthy Subjects

NCT00427141

Phase 1 Completed 48 enrolled GlaxoSmithKline
RandomizedCrossoverSingle-blindTreatment

Summary

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.

Timeline

Start
2006-10
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK580416 Unknown