A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.

Official Title
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A Phase 1, Randomized, Open-Label, 3-Period, 3-Treatment, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of LX4211 and Metformin in Healthy Subjects

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: 400 mg LX4211
* Drug: 1000 mg metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential. Body mass index (BMI)≥18 to ≤35 kg/sq m Able to provide written consent Vital signs within sponsor-defined ranges Exclusion Criteria: Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing No investigational agent or study treatment within 30 days prior to Day 1. No protein or antibody-based therapeutic agents within 3 months prior to screening Use of any tobacco product History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption History of any major surgery within 6 months prior to screening History of any serious adverse reaction or hypersensitivity to metformin or LX4211. History of renal disease or significantly abnormal kidney function test History of hepatic disease or significantly abnormal liver function test History of any active infection within 30 days prior to Day 1 History of any surgical or medical condition or clinically significant laboratory or physical finding Positive urine glucose at Screening Use of drugs or alcohol

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>400 mg LX4211 | Drug: 400 mg LX4211<br>* 400 mg of LX4211 given as a solid oral dose form<br>|
| Experimental: Treatment B<br>1000 mg metformin | Drug: 1000 mg metformin<br>* 1000 mg metformin given as a solid oral dose form<br>|
| Experimental: Treatment C<br>400 mg LX4211 + 1000 mg metformin | Drug: 400 mg LX4211<br>* 400 mg of LX4211 given as a solid oral dose form<br>Drug: 1000 mg metformin<br>* 1000 mg metformin given as a solid oral dose form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of LX4211 and metformin after concurrent single-dose administration |  | Up to 43 days, including screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary glucose excretion |  | Up to 43 days, including screening | 
| Fasting plasma glucose |  | Up to 43 days, including screening | 
| Postprandial glucose |  | Up to 43 days, including screening | 
| Insulin |  | Up to 43 days, including screening | 
| Peptide YY |  | Up to 43 days, including screening | 
| Glucagon-like peptide (GLP-1) |  | Up to 43 days, including screening | 
| Glucose-dependent insulinotropic peptide |  | Up to 43 days, including screening |