Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bexagliflozin
Intervention description: Bexagliflozin tablet, 20 mg
Intervention MeSH terms: Bexagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study was to investigate the effect of a high-fat meal on the levels of
      bexagliflozin in the blood in healthy subjects.
    

Eligibility criteria:

        Each subject had to meet the following criteria to be eligible for the study:

          1. Subjects who were between 18-65 years of age with body-mass index (BMI) between 18.0
             kg/m2 and 32.0 kg/m2.

          2. Male subjects who were surgically sterile or male subjects who were not surgically
             sterile must have agreed to refrain from donating sperm and used appropriate birth
             control for a period of 30 days after discharge from the clinic.

          3. Female subjects of childbearing potential who were willing to use an adequate method
             of contraception and to not become pregnant for the duration of the study.

          4. Female subjects who were surgically sterile or postmenopausal were eligible if they
             tested negative on the urine pregnancy test.

          5. Subjects who were non-smokers for at least 3 months prior to screening.

          6. Subjects with adequate venous access at multiple sites in both arms.

          7. Subjects who were willing and able to be confined to the clinical research facility as
             required by the Protocol.

          8. Subjects who had the ability to comprehend and willingness to provide written informed
             consent in accordance with institutional and regulatory guidelines.

        Subjects who met any of the following criteria were excluded from the study:

          1. Subjects who were determined by the Investigator or sub-Investigator to be unsuitable
             for participating in the study based on medical conditions.

          2. Female subjects who were nursing or pregnant.

          3. Subjects with a clinically significant history of allergy to drugs or latex.

          4. Subjects with a history of alcohol or drug dependence in the last 12 months.

          5. Subjects who had 400 mL of whole blood collected within four months or 200 mL of whole
             blood collected within one month of the screening test.

          6. Subjects who had blood component collection within 14 days prior to the screening
             test.

          7. Subjects who had used prescription or over-the-counter drugs within 14 days prior to
             the first dose.

          8. Subjects who had used vitamin preparations or supplements (including St. John's Wort
             and ginseng) within 14 days prior to the first dose.

          9. Subjects who had undergone strenuous activity within 72 hours prior to Day 1 in each
             period.

         10. Subjects who were unable (e.g., food intolerance) or unwilling to consume a high-fat
             breakfast within 25 minutes.

         11. Subjects who had been treated with an investigational drug within 30 days or 7
             half-lives of the investigational drug, whichever was longer, prior to the first dose
             of study drug in this trial.

         12. Subjects who had previously received EGT0001474 or bexagliflozin, or any other SGLT2
             inhibitors within 3 months from screening.

         13. Subjects whose screening electrocardiogram (ECG) demonstrated any one of the
             following: heart rate >100 bpm, QRS >120 msec, QTc >470 msec (corrected by Bazett's
             formula), PR >220 msec (a subject with PR >220 msec would generally be excluded but
             exceptions may have been allowed at the discretion of the Investigator), or any rhythm
             that was not sinus rhythm, sinus bradycardia, or sinus arrhythmia.

         14. Subjects whose sitting blood pressure was above 140/90 mmHg at screening.

         15. Subjects who had a positive result of hepatitis B surface antigen (HBsAg), hepatitis C
             virus (HCV) antibody, urinary drug or urinary cotinine test.

         16. Subjects with known human immunodeficiency virus (HIV) disease.

         17. Subjects with abnormal vital signs, laboratory values, symptoms or signs that were
             deemed clinically significant by the Investigator.

         18. Subjects who had had a febrile illness within 5 days prior to the first dose of study
             medication.

         19. Subjects vaccinated within 30 days prior to the first dose of medication.

         20. Detectable urine glucose at screening (trace or greater).

         21. Subjects with eGFR <90 mL/min/1.73 m2 or a history of kidney transplant.

         22. Subjects with digestion problems, including gastroesophageal reflux disease, irritable
             bowel syndrome, gastroparesis, and any other disorder deemed by the Investigator to be
             clinically significant.