PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy

Treatments: Drug: sotagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02471274

LX4211.1-116-HEP

LX4211.116 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Group 1

Experimental group

Description:

healthy control subjects with normal hepatic function

Treatment:

Drug: sotagliflozin

Group 2

Experimental group

Description:

subjects with mild hepatic impairment

Treatment:

Drug: sotagliflozin

Group 3

Experimental group

Description:

subjects with moderate hepatic impairment

Treatment:

Drug: sotagliflozin

Group 4

Experimental group

Description:

subjects with severe hepatic impairment

Treatment:

Drug: sotagliflozin