Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin

• Status: Completed
• Trial end date: 2017-03-01
• 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 three commonly used ant-diabetic medications, metformin, glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.

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

Details

• Lead Sponsor: Theracos
• Treatments: Bexagliflozin; Glimepiride; Metformin; Sitagliptin Phosphate

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 3 months prior to screening

3. Subjects who are willing and able to be confined to the clinical research facility as required by the protocol

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. Female subjects who are pregnant or breastfeeding

5. Subjects who are not willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic

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

7. Subjects who had previously received anti-diabetic medication, including metformin, sitagliptin, glimepiride or drugs of the same class (i.e. biguanides, DPP-4 inhibitors or sulfonylureas), or SGLT2 inhibitors, in the past 3 months