The purpose of this study is to evaluate the effect of a single oral dose of MT-7117 on the QT/QTc interval in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
29
Daytona Beach Clinical Research Unit
Daytona Beach, Florida, United States
Dallas Clinical Research Unit
Dallas, Texas, United States
Placebo-corrected, baseline-adjusted QTcF (corrected QT interval using the Fridericia formula) interval (ΔΔQTcF) at designed time points up to 24 hours post-dose
The upper bound of the one-sided 95% confidence interval (CI) for the ΔΔQTcF at geometric mean Cmax (maximum plasma concentration) level is \<10 milliseconds.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Absolute values and changes in QTcF interval, PR (retrograde P waves), and QRS (Q wave, R wave, and S wave) values from Baseline at each timepoint.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Absolute values and changes in heart rate (HR) from Baseline at each timepoint.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
The lower bound of the one-sided 95% CI of the ΔΔQTcF is >5 milliseconds at one or more individual timepoints between 1 hour and 4 hours after a single dose of moxifloxacin.
Assay sensitivity.
Time frame: 1 hour post dose, 2 hours post dose, 3 hours post dose and 4 hours post dose
The slope in concentration-response analysis for moxifloxacin is significantly positive from zero and the lower bound of the two-sided 90% CI of the predicted ΔΔQTcF at the geometric mean Cmax exceeds 5 milliseconds.
Assay sensitivity.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Proportion of subjects with a QTcF interval >=450, >=480, and >=500 milliseconds.
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Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Proportion of subjects with an increase from baseline in QTcF interval of >30 and >60 milliseconds.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Proportion of subjects with HR, PR interval, or QRS duration abnormalities.
HR \< 40 bpm (bits per minute) after a decrease of HR\>=20 bpm from Baseline, or HR \> 110 bpm after an increase of HR\>=20 bpm from Baseline. PR interval of \<100 milliseconds after a decrease of PR interval \>= 25% from Baseline, or PR interval of \>220 milliseconds after an increase of PR interval \>= 25% from Baseline. QRS duration \>120 milliseconds. Change of QRS duration \>= 25% from baseline reaching a QRS \>=120 milliseconds.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Proportion of subjects with an emergent ECG (Electrocardiogram) diagnostic abnormality.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Plasma concentration versus time profile of MT-7117 after dosing.
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Plasma PK (Pharmacokinetics) parameters for MT-7117; maximum plasma concentration (Cmax)
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Plasma PK parameters for MT-7117; time to maximum concentration (tmax)
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Plasma PK parameters for MT-7117; area under the plasma concentration-time curve from zero to the last quantifiable concentration timepoint (AUC0-last)
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Plasma PK parameters for MT-7117; area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Treatment-emergent AEs (Adverse Events) (including serious AEs [SAEs] and hepatic AEs of special interest [AESIs]).
Time frame: Day-1 to Day 5 after Period 3.