The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Dosing 1 hour before breakfast
Dosing 0.5 hour before breakfast
Dosing immediately before breakfast
Lexicon Investigational Site
San Antonio, Texas, United States
Urinary glucose excretion
Time frame: 24 hours collection on Day -1 and Days 7-13
Fasting Plasma Glucose
Time frame: Day -1 and Days 7-12
Postprandial Glucose
Time frame: Day -1 and Days 7-12
Insulin
Time frame: Day -1 and Days 7-12
Glucagon-like peptide 1 (total and active)
Time frame: Day -1 and Days 7-12
Peptide YY
Time frame: Day -1 and Days 7-12
Number of Participants with Adverse Events
Time frame: Day 1 to Day 14
Blood chemistry
Including albumin, ALP, ALT, AST, total bilirubin, glucose, BUN, calcium, carbon dioxide, chloride, cholesterol and triglycerides, creatinine, magnesium, phosphorus, potassium, sodium, protein, and uric acid.
Time frame: Day -2, Day 7 and Day 13
Hematology
Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.
Time frame: Day -2, Day 7 and Day 13
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Dosing immediately before lunch
Split dose, dosing 1 hour before breakfast and dinner