NCT05283746

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AN2 Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Epetraborole	Epetraborole hydrochloride 250 mg tablets for oral administration

Timeline

• Start date: 2022-02-21
• Primary completion: 2022-06-10
• Completion: 2022-06-27
• First posted: 2022-03-17
• Last updated: 2022-07-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study