CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Bexagliflozindrug
Likely dose
Bexagliflozin 20 mg, single oral doseAI-extracted
Key inclusion· 5
  • ✓Age 18 to 75 years
  • ✓BMI 18.0 to 40.0 kg/m²
  • ✓For hepatic impairment group: Moderate hepatic impairment with Child-Pugh score 7-9 and stable general health apart from hepatic disease
  • ✓For healthy control group: General good health with matching age (±10 years), weight (±10%), sex, and smoking status to hepatic impairment subjects
Key exclusion· 11
  • ✕History of allergy to drugs or latex
  • ✕Positive alcohol or drug screening at admission
  • ✕SGLT2 inhibitor use within 3 months or prior bexagliflozin trial participation
  • ✕Strong UGT1A9 inducers/inhibitors (probenecid, rifampin) within 2 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03557658
NCT03557658Phase 1Completed
CompareCT.gov

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

Theracos·interventional·Posted Jun 15, 2018·Updated Jun 3, 2021

In Brief

A Phase 1 clinical trial evaluating Bexagliflozin for Type2 Diabetes Mellitus. Completed, enrolled 16 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJun 15, 2018
Enrollment StartJul 26, 2018
Primary CompletionDec 26, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.0 years ago

Interventions

Bexagliflozindrug

Single oral dose of bexagliflozin tablet, 20 mg