A Study of Epetraborole Tablets in Subjects With Degrees of Renal Function

Renal Insufficiency Clinical Trial

Official title: A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics of Oral Epetraborole Tablets in Adult Subjects With Varying Degrees of Renal Function

Status Completed

Clinical Trial Summary

This is a Phase 1 study to evaluate the pharmacokinetics (PK), safety and tolerability of epetraborole tablets in adult subjects with normal renal function, subjects with various degrees of renal impairment, and subjects with end-stage renal disease (ESRD) receiving intermittent hemodialysis (IHD) therapy.

Clinical Trial Description

This is a multicenter, open-label, non-randomized, parallel group study in which a total of 40 subjects will be enrolled in one of 5 cohorts (8 subjects per cohort). Subjects will be enrolled based on their estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

• Cohort 1: Normal renal function (eGFR ≥ 90 mL/min/1.73 m2)

• Cohort 2: Mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73 m2)

• Cohort 3: Moderate renal impairment (eGFR ≥ 30 and < 60 mL/min/1.73 m2)

• Cohort 4: Severe renal impairment (eGFR < 30 mL/min/1.73 m2)

• Cohort 5: ESRD (eGFR < 15 mL/min/1.73 m2) receiving IHD. Subjects must be stable and receiving IHD at least 3 times a week for at least 3 months prior to Screening. ;

Related Conditions & MeSH terms

• Renal Insufficiency

• NCT number: NCT05283746
• Study type: Interventional
• Source: AN2 Therapeutics, Inc
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2022
• Completion date: June 27, 2022