Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 1/10/2018 |
Start Date: | September 27, 2017 |
End Date: | December 6, 2017 |
A Phase 1, Open-Label, Non-Randomized, Fixed-Sequence Composite Study to Evaluate the Effects of Probenecid, Rifampin, and Verapamil 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 three commonly prescribed medications, probenecid, verapamil
or rifampin. The study will also evaluate how safe the study drug is and how well the study
drug is tolerated when taken with probenecid, verapamil or rifampin.
study drug, bexagliflozin, with three commonly prescribed medications, probenecid, verapamil
or rifampin. The study will also evaluate how safe the study drug is and how well the study
drug is tolerated when taken with probenecid, verapamil or rifampin.
Inclusion Criteria:
1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
2. Subjects who have not used tobacco for at least 3 months before screening
3. Subjects who are willing to use an adequate form of birth control during the study and
for 30 days after discharge from clinic
4. 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 have taken an investigational drug in the past 30 days or 7 half-lives of
the investigational drug, whichever is longer
6. Subjects who had previously taken probenecid, rifampin or verapamil within 3 months of
screening
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