drugset / Trial / NCT01904214

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

NCT01904214

Phase 1 Completed 16 enrolled Novartis Pharmaceuticals
NaParallel-groupOpen-labelOther

Summary

to quantify the effect of different degrees of renal impairment on the pharmacokinetics of BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop dosing recommendations for subjects with renal impairment

Timeline

Start
2013-07
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject BAF312 Unknown 0.25 mg Oral