PK Study of Sotagliflozin in Subjects With Hepatic Impairment

• Sponsor: Lexicon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02471274
• Collaborator: (none)
• Enrollment: 32
• Locations: 4
• Arms: 4
• Patients Per Site: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment; Healthy	Drug: sotagliflozin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 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 the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 healthy control subjects with normal hepatic function	Drug: sotagliflozin; single 400 mg dose
Experimental: Group 2 subjects with mild hepatic impairment	Drug: sotagliflozin; single 400 mg dose
Experimental: Group 3 subjects with moderate hepatic impairment	Drug: sotagliflozin; single 400 mg dose
Experimental: Group 4 subjects with severe hepatic impairment	Drug: sotagliflozin; single 400 mg dose

Outcome Measures

Primary Outcome Measures

1. Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters [Day 1 to Day 5]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lexicon Investigational Site	Lakewood	Colorado	United States	80228
2	Lexicon Investigational Site	Miami	Florida	United States	33014
3	Lexicon Investigational Site	Orlando	Florida	United States	32809
4	Lexicon Investigational Site	Minneapolis	Minnesota	United States	55404

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: NCT02471274
• Other Study ID Numbers: LX4211.1-116-HEP; LX4211.116
• First Posted: Jun 15, 2015
• Last Update Posted: Nov 17, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Liver Diseases; (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 Nov 17, 2016