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

• Sponsor: Lexicon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02647918
• Collaborator: (none)
• Enrollment: 50
• Locations: 4
• Arms: 5
• Actual Duration (Months): 21
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment; Healthy	Drug: Sotagliflozin; Drug: Sotagliflozin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label, Parallel-group Study to Evaluate Sotagliflozin Safety and Pharmacokinetics in Subjects With Varying Degrees of Renal Function
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Subjects with normal renal function	Drug: Sotagliflozin; Single dose
Experimental: Group 2 Subjects with mild renal impairment	Drug: Sotagliflozin; Single dose
Experimental: Group 3 Subjects with moderate renal impairment	Drug: Sotagliflozin; Single dose
Experimental: Group 4 Subjects with severe renal impairment	Drug: Sotagliflozin; Single dose
Experimental: Group 5 Subjects with ESRD requiring HD	Drug: Sotagliflozin; 2 single doses

Outcome Measures

Primary Outcome Measures

1. Number of treatment emergent adverse events [Day 1 to Day 8]

Secondary Outcome Measures

1. Plasma concentration of sotaglifozin to evaluate AUC [Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lexicon Investigational Site	Miami	Florida	United States	33014
2	Lexicon Investigational Site	Orlando	Florida	United States	32809
3	Lexicon Investigational Site	Minneapolis	Minnesota	United States	55404
4	Lexicon Investigational Site	Saint Paul	Minnesota	United States	55114

Sponsors and Collaborators

• Lexicon Pharmaceuticals

Investigators

• Study Director: Suman Wason, MD, Lexicon Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lexicon Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02647918
• Other Study ID Numbers: LX4211.1-121-REN; LX4211.121
• First Posted: Jan 6, 2016
• Last Update Posted: Feb 26, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Renal Insufficiency; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Study Results

No Results Posted as of Feb 26, 2019