NCT03557658

Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment

A Phase 1, Open-label, Parallel-group Study to Evaluate the Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Bexagliflozin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Theracos · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This was a Phase 1, open-label, parallel-group study designed to assess the effect of moderate hepatic impairment on the PK and PD of orally administered bexagliflozin tablets. A total of 16 subjects comprising eight with moderate hepatic impairment (Child Pugh total score 7 to 9) and eight healthy, matched controls, were enrolled and received a single oral dose of bexagliflozin tablets, 20 mg, after an overnight fast. Food was withheld for at least 2 h after dosing. Water was allowed as desired except within 1 h of drug administration. Blood samples were collected prior to dosing, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose. The unbound fraction of bexagliflozin at 24 h post dose and at the maximum plasma concentration for each subject was determined by equilibrium dialysis. Urine samples for PD analysis were collected for the 12 h interval preceding dosing and for the 0 - 12 h, 12 - 24 h, 24 - 36 h, and 36 - 48 h intervals following dosing.

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Bexagliflozin	Single oral dose of bexagliflozin tablet, 20 mg

Timeline

• Start date: 2018-07-26
• Primary completion: 2018-12-26
• Completion: 2018-12-26
• First posted: 2018-06-15
• Last updated: 2021-06-03
• Results posted: 2021-05-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study