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GS-6615

Study of the Effect of GS-6615 in Subjects With LQT-3

Ensayo de GILEAD SCIENCES, INC. en Long QT Syndrome (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

24

previstos

Centros

1

Fin del objetivo primario

nov 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2013.

Qué mide

Changes in QTc intervals (Fridericia formula) (del registro, en inglés) (del inicio al dia 7)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01849003), actualizada en nov 2014.