Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets

Study Overview
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Brief Summary
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This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in healthy subjects under fasted conditions.

Official Title
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A Phase 1, Randomized, Single-center, Open-label, 2-sequence, 2-period, Single-dose Crossover Study to Evaluate Bioequivalence (Pharmacokinetics) and to Compare Total 24-hour Urinary Glucose Excretion (Pharmacodynamics) When 400 mg LX4211 is Administered as a Single 400-mg Tablet and 2 × 200-mg Tablets in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LX4211
* Drug: LX4211


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects ≥18 to ≤55 years of age Willing and able to provide written informed consent Exclusion Criteria: Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 History of renal disease, or significantly abnormal kidney function test at Screening History of hepatic disease, or significantly abnormal liver function tests at Screening History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>1 × 400-mg LX4211 tablet (fasted conditions) | Drug: LX4211<br>* Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9<br>Drug: LX4211<br>* Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9<br>|
| Experimental: Treatment B<br>2 × 200-mg LX4211 tablets (fasted conditions) | Drug: LX4211<br>* Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9<br>Drug: LX4211<br>* Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | Days 1 to 5, Days 9 to 13 | 
| Urinary Glucose Excretion (UGE) |  | Day 1, Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # of Adverse Events |  | Day 1-Day 14 |