NCT03131479

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

An Open-label, Parallel-group Study to Assess the Effect of LIK066 on Urinary Glucose Excretion, Pharmacokinetics, Safety and Tolerability Following Multiple Dose Administration in Patients With Decreased Renal Function Compared to Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	LIK066	LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.

Timeline

• Start date: 2017-04-28
• Primary completion: 2018-01-16
• Completion: 2018-01-16
• First posted: 2017-04-27
• Last updated: 2021-01-05
• Results posted: 2019-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study