Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.

Official Title
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A Phase 1b, Single-center, Double-blind, Randomized, Placebo-controlled Study on the Safety, Tolerability, and Pharmacokinetic Effects of Multiple Doses of LX4211 400 mg qd and LX4211 800 mg qd in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LX4211 400 mg
* Drug: LX4211 800 mg
* Drug: LX4211 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects ≥ 18 to ≤ 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 Willing and 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 dosing Use of any protein or antibody-based therapeutic agents within 3 months of Screening Prior exposure to LX4211 Use of cigarettes or any tobacco products within 2 months 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 14 days prior to Day 1 History of alcohol or substance abuse within 2 years prior to Day 1 Donation or loss of >400 mL of blood or blood product within 3 months of dosing Positive urine glucose at Screening Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1 Inability or difficulty swallowing pills Unable or unwilling to communicate or cooperate with the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LX4211 Low Dose<br>400 mg of LX4211 administered once daily for 10 consecutive days | Drug: LX4211 400 mg<br> <br> |
| Experimental: LX4211 High Dose<br>800 mg of LX4211 administered once daily for 10 consecutive days | Drug: LX4211 800 mg<br> <br> |
| Placebo Comparator: Placebo<br>Identical placebo administered once daily for 10 consecutive days | Drug: LX4211 Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | Up to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve |  | Days 1 through 10 |