The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.
This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Low
High
Reserch site
Kanto, Japan
Effect of Renal Function on Maximum Plasma Concentration of TA-7284
Time frame: For 72 hours after each administration
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
Time frame: For 72 hours after each administration
Effect of Renal Function on Urinary Glucose Excretion of TA-7284
Time frame: For 24 hours after each administration
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284
The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.
Time frame: For 24 hours after each administration
Adverse Events
Incidence and severity of AEs
Time frame: Upto approximately 14 days after last administration
12-lead Electrocardiogram (ECG)
Change from baseline in ECG parameters
Time frame: For 72 hours after each administration
Vital Signs
Change from baseline in Vital signs (BP, PR and BT)
Time frame: For 72 hours after each administration
Clinical Laboratory Tests
Change from baseline in Clinical laboratory tests
Time frame: For 72 hours after each administration
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