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

Primary Purpose

Renal 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 Renal Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

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 5

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Subjects with normal renal function

Subjects with mild renal impairment

Subjects with moderate renal impairment

Subjects with severe renal impairment

Subjects with ESRD requiring HD

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events

Secondary Outcome Measures

Plasma concentration of sotaglifozin to evaluate AUC

Full Information

NCT ID

NCT02647918

First Posted

December 30, 2015

Last Updated

February 25, 2019

Sponsor

Lexicon Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02647918

Brief Title

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

Official Title

A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

December 2015 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2017 (Actual)

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

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.

6. Conditions and Keywords

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

Renal 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

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Subjects with normal renal function

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Subjects with mild renal impairment

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Subjects with moderate renal impairment

Arm Title

Group 4

Arm Type

Experimental

Arm Description

Subjects with severe renal impairment

Arm Title

Group 5

Arm Type

Experimental

Arm Description

Subjects with ESRD requiring HD

Intervention Type

Drug

Intervention Name(s)

Sotagliflozin

Intervention Description

Single dose

Intervention Type

Drug

Intervention Name(s)

Sotagliflozin

Intervention Description

2 single doses

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events

Time Frame

Day 1 to Day 8

Secondary Outcome Measure Information:

Title

Plasma concentration of sotaglifozin to evaluate AUC

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

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

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

Facility Name

Lexicon Investigational Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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