NCT05995444

A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects

A Phase 1, Single-Dose, Randomized, Placebo- and Positive-Control, Four-Way, Crossover Study for the Evaluation of the Effect of Epetraborole on QT Intervals in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AN2 Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A single-center, 4-way crossover study to evaluate the effect of single therapeutic and supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.

Detailed description

On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole-matching placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period. There will be a washout of at least 10 days between doses.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Epetraborole and matching placebo	Treatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets)
DRUG	Epetraborole	Treatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets)
DRUG	Placebo	Treatment C (Placebo control): Epetraborole matching-placebo (8 tablets)
DRUG	Moxifloxacin	Treatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet)

Timeline

• Start date: 2023-06-05
• Primary completion: 2023-07-26
• Completion: 2023-08-03
• First posted: 2023-08-16
• Last updated: 2023-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study