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PK Study of Sotagliflozin in Subjects With Hepatic Impairment

NCT ID: NCT02471274

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatic Impairment Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

healthy control subjects with normal hepatic function

Group Type EXPERIMENTAL

sotagliflozin

Intervention Type DRUG

single 400 mg dose

Group 2

subjects with mild hepatic impairment

Group Type EXPERIMENTAL

sotagliflozin

Intervention Type DRUG

single 400 mg dose

Group 3

subjects with moderate hepatic impairment

Group Type EXPERIMENTAL

sotagliflozin

Intervention Type DRUG

single 400 mg dose

Group 4

subjects with severe hepatic impairment

Group Type EXPERIMENTAL

sotagliflozin

Intervention Type DRUG

single 400 mg dose

Interventions

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sotagliflozin

single 400 mg dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suman Wason, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

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Lexicon Investigational Site

Lakewood, Colorado, United States

Site Status

Lexicon Investigational Site

Miami, Florida, United States

Site Status

Lexicon Investigational Site

Orlando, Florida, United States

Site Status

Lexicon Investigational Site

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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LX4211.116

Identifier Type: OTHER

Identifier Source: secondary_id

LX4211.1-116-HEP

Identifier Type: -

Identifier Source: org_study_id