PK Study of Sotagliflozin in Subjects With Hepatic Impair... | NCT02471274

Studies
PK Study of Sotagliflozin in Subjects With Hepatic Impairment

NCT02471274

Sponsor

Lexicon Pharmaceuticals

Status

Completed

Last Update Posted

Nov 17, 2016Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Hepatic Impairment
Healthy

Interventions

sotagliflozin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
LX4211.116	Other Identifier	Lexicon Pharmaceuticals, Inc.

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Not provided

First Submitted Date

Jun 11, 2015

First Submission Date that Met QC Criteria

Jun 12, 2015

First Posted Date

Jun 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2016

Last Update Posted Date

Nov 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
sotagliflozin	Drug	single 400 mg dose	Group 1 Group 2 Group 3 Group 4

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suman Wason, MD	Lexicon Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lexicon Investigational Site		Lakewood	Colorado	80228	United States
Lexicon Investigational Site

Intervention Browse Module

MeSH Terms

ID	Term
C575681	(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided