Bexagliflozin Drug/Drug Interaction Study With Digoxin
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the drug-drug interaction in your body when given the
      study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate
      whether bexagliflozin effects the amount of digoxin in your blood and how safe the study drug
      is and how well the study drug is tolerated when taken with digoxin.
    

Detailed description: 
      This was a phase 1, single center, open-label, two-period, two-treatment, crossover study to
      evaluate the effect of bexagliflozin tablets, 20 mg, on the pharmacokinetics (PK) of digoxin,
      0.5 mg after co-administration in healthy subjects. Each subject was randomized into one of 2
      treatment groups and participated in 2 treatment periods as outlined below. During the
      duration of the study, each subject received 8 single doses of bexagliflozin and 2 single
      doses of digoxin. Clinical laboratory tests and safety monitoring were conducted during
      Periods 1 and 2.

      Group 1 - Period 1, Treatment A Subjects were admitted to the clinic on Day 0. Subjects
      received daily oral doses of a bexagliflozin tablet, 20 mg, starting on Day 1 for 8 days, and
      a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with
      bexagliflozin on Day 3. Blood samples for PK were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3,
      4, 6, 8, and 12 hours (h) on Day 3, 24 h (Day 4), 48 h (Day 5), 72 h (Day 6), 96 h (Day 7),
      and 120 h (Day 8) after administration of digoxin. Subjects were discharged on Day 8.

      Group 1 - Period 2, Treatment B Subjects were admitted to the clinic on Day 18. On Day 19,
      subjects received a single oral dose of 0.5 mg digoxin. Blood samples for PK were drawn at
      pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 h on Day 19, 24 h (Day 20), 48 h (Day 21),
      72 h (Day 22), 96 h (Day 23), and 120 h (Day 24) after administration of digoxin. Subjects
      were discharged on Day 24.

      Group 2 - Period 1, Treatment B Subjects were admitted to the clinic on Day 0. On Day 1,
      subjects received a single oral dose of 0.5 mg digoxin. Blood samples for PK were drawn at
      pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 h on Day 1, 24 h (Day 2), 48 h (Day 3), 72
      h (Day 4), 96 h (Day 5), and 120 h (Day 6) after administration of digoxin. Subjects were
      discharged on Day 6.

      Group 2 - Period 2, Treatment A Subjects were admitted to the clinic on Day 14. Subjects
      received daily oral doses of a bexagliflozin tablet, 20 mg, for 8 days starting on Day 15,
      and a single oral dose of 0.5 mg digoxin (two 0.25 mg tablets) was co-administered with
      bexagliflozin on Day 17. Blood samples for PK were drawn at pre-dose and at 0.5, 1, 1.5, 2,
      3, 4, 6, 8, and 12 h on Day 17, 24 h (Day 18), 48 h (Day 19), 72 h (Day 20), 96 h (Day 21),
      and 120 h (Day 22) after administration of digoxin. Subjects were discharged on Day 22.
    

Intervention name(s): Bexagliflozin; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Bexagliflozin tablets, 20 mg; 2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
Other intervention name(s): EGT0001442, EGT0001474
Intervention MeSH terms: Bexagliflozin; Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment