NCT02647918
Completed
Phase 1
A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function
Overview
- Phase
- Phase 1
- Intervention
- Sotagliflozin
- Conditions
- Renal Impairment
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of treatment emergent adverse events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Group 5
Subjects with ESRD requiring HD
Intervention: Sotagliflozin
Group 1
Subjects with normal renal function
Intervention: Sotagliflozin
Group 2
Subjects with mild renal impairment
Intervention: Sotagliflozin
Group 3
Subjects with moderate renal impairment
Intervention: Sotagliflozin
Group 4
Subjects with severe renal impairment
Intervention: Sotagliflozin
Outcomes
Primary Outcomes
Number of treatment emergent adverse events
Time Frame: Day 1 to Day 8
Secondary Outcomes
- Plasma concentration of sotaglifozin to evaluate AUC(Day 1)
Study Sites (1)
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