A Phase 1 interventional study of Bexagliflozin and Digoxin in Type2 Diabetes Mellitus, sponsored by Theracos. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by Theracos · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Drug: Digoxin
Drug: Bexagliflozin · Drug: Digoxin
Bexagliflozin tablets, 20 mg
Also known as: EGT0001442, EGT0001474
2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
Digoxin Cmax (Maximum Observed Plasma Concentration)
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
Time frame: Up to 120 hours
Digoxin Tmax (Time of Maximum Observed Plasma Concentration)
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
Time frame: Up to 120 hours
Digoxin T1/2 (Apparent Terminal Elimination Half-life)
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
Time frame: Up to 120 hours
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
Time frame: Up to 120 hours
| Milestone | Digoxin and Bexagliflozin Tablet, Then Digoxin Alone | Digoxin, Then Digoxin and Bexagliflozin |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 9 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
| ng/mL | Digoxin Alone | Digoxin With Bexagliflozin |
|---|---|---|
| Digoxin Cmax (Maximum Observed Plasma Concentration) | 2.315 ± 28.8 | 2.301 ± 40.9 |
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
| hours | Digoxin Alone | Digoxin With Bexagliflozin |
|---|---|---|
| Digoxin Tmax (Time of Maximum Observed Plasma Concentration) | 1.00 (1 to 2) | 1.00 (1 to 4) |
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
| hours | Digoxin Alone | Digoxin With Bexagliflozin |
|---|---|---|
| Digoxin T1/2 (Apparent Terminal Elimination Half-life) | 34.3 ± 15.5 | 38.2 ± 15.7 |
Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin
| h*ng/mL | Digoxin Alone | Digoxin With Bexagliflozin |
|---|---|---|
| AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) | 35.558 ± 16.6 | 37.805 ± 27.5 |
Collected over Adverse event data were collected from Day 0 up to Day 24 of the study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Digoxin Alone | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| Digoxin With Bexagliflozin | 0/19 (0%) | 0/19 (0%) | 5/19 (26.3%) |
| Event | Digoxin Alone | Digoxin With Bexagliflozin |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 1/20 | 1/19 |
| Urinary tract infectionInfections and infestations | 0/20 | 1/19 |
| FatigueGeneral disorders | 0/20 | 1/19 |
| PalpitationsCardiac disorders | 0/20 | 1/19 |
| NauseaGastrointestinal disorders | 1/20 | 1/19 |
| ExcoriationInjury, poisoning and procedural complications | 0/20 | 1/19 |
| HypoglycemiaMetabolism and nutrition disorders | 0/20 | 1/19 |
| DizzinessNervous system disorders | 0/20 | 1/19 |
| Medical device site reactionGeneral disorders | 1/20 | 0/19 |
| Vision blurredEye disorders | 1/20 | 0/19 |
Safety population includes subjects dosed with any study drug.
| Age, Continuous(years) | Bexagliflozin and Digoxin, Then Digoxin Alone | Digoxin Alone, Then Bexagliflozin and Digoxin | Total |
|---|---|---|---|
| Mean | 44.8 ± 8.84 | 35.2 ± 6.37 | 40.0 ± 8.97 |
| Sex: Female, Male(Participants) | Bexagliflozin and Digoxin, Then Digoxin Alone | Digoxin Alone, Then Bexagliflozin and Digoxin | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 5 | 5 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Bexagliflozin and Digoxin, Then Digoxin Alone | Digoxin Alone, Then Bexagliflozin and Digoxin | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 7 | 12 |
| Not Hispanic or Latino | 5 | 3 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Bexagliflozin and Digoxin, Then Digoxin Alone | Digoxin Alone, Then Bexagliflozin and Digoxin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 6 | 7 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kg) | Bexagliflozin and Digoxin, Then Digoxin Alone | Digoxin Alone, Then Bexagliflozin and Digoxin | Total |
|---|---|---|---|
| Mean | 73.6 ± 11.28 | 74.2 ± 13.67 | 73.9 ± 12.20 |
| Height(cm) | Bexagliflozin and Digoxin, Then Digoxin Alone | Digoxin Alone, Then Bexagliflozin and Digoxin | Total |
|---|---|---|---|
| Mean | 167.1 ± 8.44 | 165.6 ± 9.35 | 166.4 ± 8.71 |
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