drugset / Trial / NCT01480609

Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite

NCT01480609 ↗

Phase 1 Completed 8 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelTreatment

Summary

This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8 patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis. Patients will remain in the unit during each treatment period from admission to the collection of the final PK sample. The doses of ezogabine/retigabine in the two treatment periods will be separated by at least 7 days.

Timeline

Start
2011-11-30
Primary completion
2012-04-24
Completion
2012-04-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ezogabine Small molecule 100 mg Oral

Indications