PK Study of Sotagliflozin in Subjects With Hepatic Impairment
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function
To evaluate the effect of mild, moderate, or severe hepatic impairment on the
pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared
with healthy, demographically-matched subjects.
pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared
with healthy, demographically-matched subjects.
Inclusion Criteria:
- Adult male and female subjects ≥18 to ≤70 years of age
- Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening
- Subjects with mild, moderate, or severe hepatic impairment
- Control group of matched healthy subjects
- Willing and able to provide written informed consent
Exclusion Criteria:
- Presence of clinically significant physical, laboratory, or ECG findings that may
interfere with any aspect of study conduct or interpretation of results
- Existence of any surgical or medical condition that might interfere with the
absorption, distribution, metabolism, or excretion of sotagliflozin
- History of any major surgery within 6 months
- History of renal disease, or significantly abnormal kidney function test
- Women who are breastfeeding or are planning to become pregnant during the study
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