drugset / Trial / NCT03131479

Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

NCT03131479

Phase 2 Completed 53 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the body does to the drug. The results of this study may be used to help determine whether LIK066 can be used to treat people with reduced kidney function and the proper dosing regimen.

Timeline

Start
2017-04-28
Primary completion
2018-01-16
Completion
2018-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject licogliflozin Small molecule 50 mg Oral