Healthy, Renal Impairment
Conditions
Brief summary
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.
Interventions
DRUGSotagliflozin
Single dose
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult male and female subjects ≥18 to ≤75 years of age * Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening * Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD * 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 hepatic disease, or significantly abnormal liver function test * Women who are breastfeeding or are planning to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events | Day 1 to Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of sotaglifozin to evaluate AUC | Day 1 |
Countries
United States
Outcome results
None listed