Study of the Effect of GS-6615 in Subjects With LQT-3
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
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.