Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Impairment

Treatments: Drug: Sotagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02647918

LX4211.121 (Other Identifier)

LX4211.1-121-REN

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

Group 1

Experimental group

Description:

Subjects with normal renal function

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin

Group 2

Experimental group

Description:

Subjects with mild renal impairment

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin

Group 3

Experimental group

Description:

Subjects with moderate renal impairment

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin

Group 4

Experimental group

Description:

Subjects with severe renal impairment

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin

Group 5

Experimental group

Description:

Subjects with ESRD requiring HD

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin