Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 78 |
| Updated: | 2/8/2019 |
| Start Date: | April 28, 2017 |
| End Date: | January 16, 2018 |
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
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.
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.
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- Male and female subjects age 18-78 years, inclusive, with controlled health condition
as determined by past medical history, physical examination, electrocardiogram and
laboratory test at screening.
- patients with Type 2 diabetes, HbA1c <10% at screening.
- Body mass index (BMI) ≤ 50 kg/m^2 at screening.
Exclusion Criteria:
- Patients with Type 1 diabetes
- Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline
phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.
- Patients undergoing any method of dialysis
- clinically significant GI disorder related to malabsorption or that may affect drug or
glucose absorption.
- subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6
months of screening visit.
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