Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects

Study Overview
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Brief Summary
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This phase 1 study is to evaluate the pharmacokinetics (PK), metabolism, routes and extent of elimination of a single oral dose of 400 mg [14C]LX4211 to healthy male subjects

Official Title
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A Phase 1, Open-label, Nonrandomized, Single Dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-LX4211, Following Oral Administration, in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]-LX4211


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥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 Historically able to produce a minimum of 1 bowel movement per day Willing and able to provide written informed consent Exclusion Criteria: Female Receipt of any investigational drug within 30 days prior to Dosing, or investigational protein or antibody-based therapeutic agents within 3 months prior to Screening Prior exposure to LX4211 Use any tobacco product within 2 months prior to Screening and while participating in the study (Day -1 through Discharge) History of bariatric surgery or any other GI surgery that may induce malabsorption History of any major surgery within 6 months prior to Screening History of renal or hepatic disease, or significantly abnormal kidney or liver function tests at Screening History of any clinically relevant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, hematological, or GI abnormality History of any active infection within 14 days prior to Dosing History of alcohol or substance abuse within 2 years prior to Dosing History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 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 at Screening or Day -1 Positive breath test for alcohol at Screening or Day -1 Participation in >1 other radiolabeled investigational study drug trial within 12 months prior to Day -1 Exposure to significant radiation within 12 months prior to Day -1

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

Sexes Eligible for Study
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Male

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-LX4211<br>400 mg LX4211 administered orally | Drug: [14C]-LX4211<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) |  | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing an adverse event |  | Day 1 through discharge | 
| Urinary recovery of radioactivity |  | predose through 24 hours | 
| Fecal recovery of radioactivity |  | predose through 24 hours | 
| Whole blood and plasma concentration of total radioactivity |  | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose |