drugset / Trial / NCT02084199

Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects

NCT02084199

Phase 1 Completed 24 enrolled Lakefront Biotherapeutics NV
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This will be an open label study to assess the influence of renal impairment on the pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of 100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls. Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls will be evaluated.

Timeline

Start
2014-03
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Filgotinib Small molecule 100 mg Oral