Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/27/2019 |
| Start Date: | July 26, 2018 |
| End Date: | December 26, 2018 |
A Phase 1, Open-label, Parallel-group Study to Evaluate the Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Bexagliflozin
The purpose of this study is to examine the drug exposure and drug effects on subjects with
moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg. The
study will also evaluate how safe the study drug is and how well the study drug is tolerated
in subjects with moderate hepatic impairment.
moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg. The
study will also evaluate how safe the study drug is and how well the study drug is tolerated
in subjects with moderate hepatic impairment.
Inclusion Criteria:
- Body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2.
- Willing and able to stay at the clinical research facility as required by the protocol
Exclusion Criteria:
- History of allergy to drugs or latex.
- Donated a significant amount of blood in the past 2 weeks.
- Female subjects who are pregnant or breastfeeding.
- Not willing to use an adequate form of birth control during the study and for 30 days
after discharge from clinic.
- Having taken the investigational drug in the past 30 days
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