drugset / Trial / NCT01241669

Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity

NCT01241669

Phase 1 Completed 104 enrolled Eisai Inc.
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a drug-drug interaction study to evaluate the effects of steady-state exposure of E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of E5555 on several renal function parameters.

Timeline

Start
2010-10
Primary completion
2011-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Atopaxar Small molecule 100 mg Oral
Subject Atopaxar Small molecule 400 mg Oral
Subject Metformin Small molecule 500 mg Oral

Indications

No indication recorded.