Phase 1 Study of Epetraborole Tablets

Summary

Participation Requirements

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 t...

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.

Tracking Information