Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy Subjects

Inclusion criteria

• Adult subjects ≥18 to ≤55 years of age
• Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
• Body mass index (BMI) ≥18 and ≤35 kg/sq m
• Able and willing to provide written informed consent
• Nonsmoker and has not used any tobacco products for at least 3 months prior to Screening
• Willing to adhere to the prohibitions and restrictions specified in this protocol
• Able to tolerate prolonged periods of quiet, motionless, supervised rest

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 prior to Screening
• Use of any protein or antibody-based therapeutic agents within 3 months prior to Screening
• Prior exposure to LX4211
• Daily use of cigarettes or any tobacco products within 3 months prior to Screening and while participating in the study
• History of any major surgery within 6 months prior to Screening
• History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211
• History of renal disease or significantly abnormal kidney function tests
• History of hepatic disease or significantly abnormal liver function tests
• Women who are breastfeeding or are planning to become pregnant during the study
• History of any active infection within 14 days prior to Screening
• History of alcohol or substance abuse within 2 years prior to Screening
• History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
• Presence of clinically significant physical, laboratory, or ECG findings (eg, QTcF >450 msec for females and QTcF >430 msec for males) at Screening
• >30 premature ventricular beats per hour on the telemetry ECG monitoring at Day -2 of Period 1
• History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)
• Any skin condition likely to interfere with ECG electrode placement or adhesion
• Any skin condition likely to interfere with ECG electrode placement or adhesion
• Donation or loss of >400 mL of blood or blood product within 3 months prior to Screening
• Positive urine glucose during Screening
• Positive pregnancy test during Screening
• Positive urine screen for drugs of abuse during Screening
• Positive urine test for alcohol during Screening
• Inability or difficulty swallowing whole tablets or capsules
• Unable or unwilling to communicate or cooperate with the Investigator for any reason