drugset / Trial / NCT01114607

A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects

NCT01114607

Phase 1 Completed 24 enrolled GlaxoSmithKline
RandomizedSingle-groupOpen-labelBasic science

Summary

This is an open-label, single dose, randomized, five-period, crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb, PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study. Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.

Timeline

Start
2010-05-05
Primary completion
2010-06-29
Completion
2010-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject vercirnon Small molecule 500 mg

Indications