NCT04892641

Phase 1 Study of Epetraborole Tablets

A Phase 1, Double-blind, Placebo-controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Epetraborole Tablets Administered for up to 28 Days in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: AN2 Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days.

Detailed description

Up to 56 healthy male and female adult subjects will be enrolled into one of 7 Dose Cohorts (Dose Cohorts 1 to 7; n = 8 per cohort). Cohort 7 (n = 8) is a Food Effect Cohort and subjects will receive a single dose of epetraborole or placebo in a Fasted state (Period 1) followed by a second dose of the same Investigational Product (IP) in a Fed state (Period 2) after a washout period of at least 7 days (+3 days). The dose of IP to be administered in Cohort 7 will be determined based on the Safety Monitoring Group recommendation following evaluation of safety and available PK data (at least 14 days) in Cohort 1 through Cohort 6. Up to 16 additional subjects may be included for the purposes of cohort expansion or to explore a dose intermediate to previously evaluated doses. Subjects in each Dose Cohort (n=8) will be randomized 3:1 to receive epetraborole (n=6) or matching placebo (n=2) and will receive oral doses of epetraborole or placebo. Investigational product will be administered with approximately 240 mL (8 fluid ounces) of non-carbonated water to each subject following an overnight fast of at least 8 hours, except for Period 2 (Fed) of Cohort 7. Subjects will be required to fast for a minimum of 2 hours following administration of IP.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Epetraborole	Epetraborole hydrochloride 250 mg tablets for oral administration
DRUG	Placebo	Matching placebo for 250 mg epetraborole hydrochloride tablets for oral administration

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-02-26
• Completion: 2022-02-26
• First posted: 2021-05-19
• Last updated: 2024-03-21

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study