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

NCT05283746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-15

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency

Interventions

DRUG

Epetraborole

Epetraborole hydrochloride 250 mg tablets for oral administration

Sponsors & Collaborators

  • AN2 Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Kimberly S Cruz, MD · Advanced Pharma CR LLC

  • Thomas C Marbury, MD · Orlando Clinical Research Center

  • George C Canas, MD · Nucleus Network Pty Ltd.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2022-06-10
Completion
2022-06-27
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 NCT05283746 on ClinicalTrials.gov