PK Study of Sotagliflozin in Subjects With Hepatic Impairment

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02471274

Enrollment

Registered

2015-06-15

Start date

2015-06-30

Completion date

Unknown

Last updated

2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hepatic Impairment

Brief summary

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.

Interventions

DRUGsotagliflozin

single 400 mg dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters	Day 1 to Day 5

Secondary

Measure	Time frame
Number of treatment emergent adverse events	Day 1 to Day 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026