423001
Tempe, Arizona, 85283, United States
NCT Number: NCT05995444
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
14 days prior to the first dosing.
Treatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets)
Other names: Therapeutic
Treatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets)
Other names: Supratherapeutic
Treatment C (Placebo control): Epetraborole matching-placebo (8 tablets)
Other names: Placebo Control
Treatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet)
Other names: Positive Control
Time frame: Study Day -1 to Study Day 2
Effect of epetraborole plasma concentrations on the QTc interval using linear mixed effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest.
Time frame: Study Day -1 to Study Day 2
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QTc
Time frame: Study Day -1 to Study Day 2
Assay sensitivity assessment with ddQTc at the geometric mean Cmax value predicted from a linear mixed effect model evaluating the relationship between QTc and moxifloxacin plasma concentrations (exposure-response modeling).
Time frame: Study Day -1 to Study Day 2
QTc interval using a mixed effect analysis of covariance (ANCOVA) carried out as appropriate to analyze dQTc at each time point post baseline.
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 t
Time frame: Study Day 1 through Study Day 14
TEAEs
Time frame: Study Day 1 through Study Day 14
Measure Safety Vital Signs changes of body temperature
Time frame: Study Day 1 through Study Day 14
Measure Orthostatic Vital Signs changes of Heart Rate from supine to standing position.
Time frame: Study Day -1 to Study Day 2
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on, PR
Time frame: Study Day -1 to Study Day 2
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration.
Time frame: Study Day -1 to Study Day 2
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on HR.
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 inf
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of AUC%extrap
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of Cmax
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of Tmax
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of Kel
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of t½
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of CL/F (parent only),
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of Vz/F (parent only
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 t
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 inf
Time frame: Study Day -1 to Study Day 2
Analysis of PK Concentration for epetraborole and metabolite M3 of MR Cmax
Time frame: Study Day 1 through Study Day 14
Measure Safety Vital Signs changes of respiratory rate
Time frame: Study Day 1 through Study Day 14
Measure Safety Vital Signs changes of blood pressure (systolic and diastolic)
Time frame: Study Day 1 through Study Day 14
measure Safety Vital Signs changes of heart rate
Time frame: Study Day 1 through Study Day 14
Measure Orthostatic Vital Signs changes of blood pressure from supine to standing position (systolic and diastolic).
AN2 Therapeutics, Inc
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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