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Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment

NCT03557658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-06-03

Study results available
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Summary

The purpose of this study is to examine the drug exposure and drug effects on subjects with moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg. The study will also evaluate how safe the study drug is and how well the study drug is tolerated in subjects with moderate hepatic impairment.

Conditions

  • Type2 Diabetes Mellitus

Interventions

DRUG

Bexagliflozin

Single oral dose of bexagliflozin tablet, 20 mg

Sponsors & Collaborators

  • Theracos

    lead INDUSTRY

Principal Investigators

  • J. P. Lock, M.D. · Theracos Sub, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2018-12-26
Completion
2018-12-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557658 on ClinicalTrials.gov