NCT02471274

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

June 11, 2015

Last Update Submit

November 15, 2016

Conditions

Hepatic ImpairmentHealthy

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters

    Day 1 to Day 5

Secondary Outcomes (1)

  • Number of treatment emergent adverse events

    Day 1 to Day 8

Study Arms (4)

Group 1

EXPERIMENTAL

healthy control subjects with normal hepatic function

Drug: sotagliflozin

Group 2

EXPERIMENTAL

subjects with mild hepatic impairment

Drug: sotagliflozin

Group 3

EXPERIMENTAL

subjects with moderate hepatic impairment

Drug: sotagliflozin

Group 4

EXPERIMENTAL

subjects with severe hepatic impairment

Drug: sotagliflozin

Interventions

sotagliflozinDRUG

single 400 mg dose

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lexicon Investigational Site

Lakewood, Colorado, 80228, United States

Location

Lexicon Investigational Site

Miami, Florida, 33014, United States

Location

Lexicon Investigational Site

Orlando, Florida, 32809, United States

Location

Lexicon Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Study Officials

  • Suman Wason, MD

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 15, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

US(4)