Bexagliflozin Drug/Drug Interaction Study With Digoxin

• Status: Completed
• Trial end date: 2017-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Theracos
• Treatments: Bexagliflozin; Digoxin

Criteria

Inclusion Criteria:

1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2

2. Subjects who are non-smokers for at least 6 months prior to first dose

3. Subjects who are willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic

Exclusion Criteria:

1. Subjects with a clinically significant history of allergy to drugs or latex

2. Subjects with a history of alcohol or drug dependence in the past 12 months

3. Subjects who have donated a significant amount of blood in the past 2 months

4. Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer

5. Subjects who had previously received digoxin or drugs of the same class, or SGLT2 inhibitors, in the past 3 months