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PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Primary Purpose

Hepatic Impairment, Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

sotagliflozin

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Lexicon Investigational Site
Lexicon Investigational Site
Lexicon Investigational Site
Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

healthy control subjects with normal hepatic function

subjects with mild hepatic impairment

subjects with moderate hepatic impairment

subjects with severe hepatic impairment

Outcomes

Primary Outcome Measures

Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters

Secondary Outcome Measures

Number of treatment emergent adverse events

Full Information

NCT ID

NCT02471274

First Posted

June 11, 2015

Last Updated

November 15, 2016

Sponsor

Lexicon Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02471274

Brief Title

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

healthy control subjects with normal hepatic function

Arm Title

Group 2

Arm Type

Experimental

Arm Description

subjects with mild hepatic impairment

Arm Title

Group 3

Arm Type

Experimental

Arm Description

subjects with moderate hepatic impairment

Arm Title

Group 4

Arm Type

Experimental

Arm Description

subjects with severe hepatic impairment

Intervention Type

Drug

Intervention Name(s)

sotagliflozin

Intervention Description

single 400 mg dose

Primary Outcome Measure Information:

Title

Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters

Time Frame

Day 1 to Day 5

Secondary Outcome Measure Information:

Title

Number of treatment emergent adverse events

Time Frame

Day 1 to Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suman Wason, MD

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Lexicon Investigational Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Lexicon Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Lexicon Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Lexicon Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Learn more about this trial

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

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