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

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal 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

Subjects with normal renal function

Group Type EXPERIMENTAL

Sotagliflozin

Intervention Type DRUG

Single dose

Group 2

Subjects with mild renal impairment

Group Type EXPERIMENTAL

Sotagliflozin

Intervention Type DRUG

Single dose

Group 3

Subjects with moderate renal impairment

Group Type EXPERIMENTAL

Sotagliflozin

Intervention Type DRUG

Single dose

Group 4

Subjects with severe renal impairment

Group Type EXPERIMENTAL

Sotagliflozin

Intervention Type DRUG

Single dose

Group 5

Subjects with ESRD requiring HD

Group Type EXPERIMENTAL

Sotagliflozin

Intervention Type DRUG

2 single doses

Interventions

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Sotagliflozin

Single dose

Intervention Type DRUG

Sotagliflozin

2 single doses

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes