This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Single administration
Daily administration for a total of 12 dosing days
Placebo will be matched to Moxifloxacin or ALKS 5461
Alkermes Investigational Site
Overland Park, Kansas, United States
Change in QT interval corrected for heart rate using the Fridericia formula (QTcF)
Time frame: Up to 14 days
Change in heart rate
Time frame: Up to 14 days
Incidence of abnormal ECG
Time frame: Up to 13 days
Tabulation of ECG morphology
Findings not present at baseline
Time frame: Up to 14 days
Correlation of plasma drug levels with QT interval
Time frame: Up to 14 days
Maximum observed plasma concentration (Cmax) for ALKS 5461
Time frame: Up to 14 days
Incidence of adverse events (AEs)
Time frame: Up to 14 weeks
Change in PR interval
Time frame: Up to 14 days
Change in QRS interval
Time frame: Up to 14 days
Time to reach the maximum plasma concentration (Tmax) for ALKS 5461
Time frame: Up to 14 days
AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
Time frame: Up to 14 days
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AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Time frame: Up to 14 days
Terminal elimination half-life (T1/2) for ALKS 5461
Time frame: Up to 14 days