A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.

Inclusion Criteria:

• Adults ≥18 and ≤55 years of age
• Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
• Body mass index (BMI) ≥18 and ≤35 kg/sq m
• Able to provide written informed consent

Exclusion Criteria:

• Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
• Use of any investigational agent or study treatment within 30 days of Day 1
• Use of any protein or antibody-based therapeutic agents within 3 months of Screening
• Prior exposure to any SGLT inhibitor
• Use of cigarettes or any tobacco products within 6 weeks prior to Screening and while participating in the study
• History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
• History of any major surgery within 6 months of Screening
• History of any hypersensitivity to the inactive components of LX4211
• History of renal disease or significantly abnormal kidney function tests
• History of hepatic disease or significantly abnormal liver function tests
• History of any active infection within 30 days of Day 1
• History of alcohol or substance abuse within 2 years prior to Day 1
• Positive urine glucose at Screening
• Positive pregnancy test at Screening
• Inability or difficulty swallowing whole tablets or capsules
• Unable or unwilling to communicate or cooperate with the Investigator.