Long QT Syndrome Clinical Trial
Official title:
An Open-label Study to Evaluate the Effect of Single Dose GS-6615 on QT, Safety and Tolerability in Subjects With Long QT-3 Syndrome
This mechanism of action study is to evaluate the effect of oral GS-6615 on the QTc interval
in participants with Long QT-3 syndrome. This study will be performed in six cohorts of
participants in a sequential manner, four single-dose cohorts followed by two multiple-dose
cohorts. Duration of treatment for the single-dose cohorts and multiple-dose cohorts will be
1 day and 7 days, respectively. Participants will be confined at the study center from
check-in until completion of assessments at discharge.
Participants will be continuously monitored using real-time telemetry throughout the
in-clinic confinement. Physical examinations including vital signs, laboratory analysis,
electrocardiograms (ECGs), Holter recordings and echocardiography (ECHO) will be performed
at defined time points throughout the study period. Assessment of adverse events and
concomitant medications will continue throughout the duration of the study.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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