P2318Individual-specific corrected QT interval (QTcI) obtained from ECGs recorded at fixed timepoints versus QTcI derived using a wider range of stable heart rates from 24-hour Holter recordings

Evaluation of the Effect of Maribavir on Cardiac Repolarization in Healthy Participants: Thorough QT/QTc Study

“…Two participants discontinued the study; the first participant due to a TEAE of upper respiratory infection, which occurred after receiving moxifloxacin, and the second participant discontinued the study due to a family emergency before they would have received maribavir 1,200 mg. There was a total of 133 TEAEs reported (13,20,29, and 71, among participants receiving placebo, moxifloxacin 400 mg, maribavir 100 mg, and maribavir 1,200 mg, respectively). All TEAEs were mild in intensity.…”

“…The curvature of the individual QT–RR determined the variance in participant‐specific QTcIb. This correction procedure reduces the variance compared with conventional corrections, such as QTcF or QTcB, producing a more reliable and reproducible QT estimate for calculating the primary end point of the study 28,29 . The baseline‐corrected QTcIb, where baseline was the average of the three predose values obtained on day 1 of treatment period 1, were calculated for each treatment.…”