Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:8/23/2017
Start Date:June 20, 2017
End Date:June 29, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1, Open-label, Randomized, Two-period, Two-treatment, Crossover Study to Evaluate the Effect of Exenatide on the Pharmacokinetics and Pharmacodynamics of Bexagliflozin in Healthy Subjects

The purpose of this study is to examine the drug-drug interaction in your body when given the
study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1
receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug
is and how well the study drug is tolerated when administered with exenatide injection.


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 exenatide, or any other GLP-1 RAs within 3 months
from screening.
We found this trial at
1
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Clinical Research Site
Evansville, Indiana 47710
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Evansville, IN
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