Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05995444
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2023-06-27
Brief Title:
A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects
Sponsor:
AN2 Therapeutics Inc
Organization:
AN2 Therapeutics Inc
Study Overview
Official Title:
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
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
There will be a washout of at least 10 days between doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None