drugset / Trial / NCT01827631

Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects

NCT01827631

Phase 1 Completed 21 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.

Timeline

Start
2013-05-27
Primary completion
2013-06-14
Completion
2013-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject vercirnon Small molecule 500 mg

Indications