Date: 2014-05-09
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the annual meeting of the Heart Rhythm Society in San Francisco
Company: Gilead (USA)
Product: GS-6615
Action mechanism:
Disease: long QT-3 (LQT3) syndrome
Therapeutic area: Cardiovascular diseases - Genetic diseases
Country: USA
Trial
details: The purpose of 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 five cohorts of participants in a sequential manner, four single-dose cohorts followed by one multiple-dose cohort. (NCT01849003)
Latest
news: * On May 9, 2014, Gilead Sciences announced results from a Phase 1 clinical trial (GS-US-279-0110) of GS-6615, an investigational, selective late sodium current inhibitor, showing a shortening of the QTc interval (the time interval between the start of the Q-wave and end of the T-wave in the heart\'s electrical cycle) in patients with long QT-3 (LQT3) syndrome. Results from this study (Abstract #AB34-05) have been presented in San Francisco at the annual meeting of the Heart Rhythm Society. In this study, ten LQT3 patients were evaluated at the Clinical Research Center at the University of Rochester, where they received single oral doses of GS-6615 ranging from 10 mg to 60 mg. The study enrolled patients with a QTc above 480 ms. The QTc pre-dose (Day -1) was compared to QTc on drug (Day 1) during time-matched 12-hour periods. In the study, QTc shortening was observed at all dose levels, with maximal QTc shortening ranging from -44 ms to -80 ms. No safety concerns were observed during administration with GS-6615. Based on these results, Gilead plans to initiate a Phase 2 study of GS-6615 in LQT3 patients later this year. Additionally, based on pre-clinical data for GS-6615 and clinical data involving the role of late sodium current inhibition in other cardiovascular diseases, Gilead plans to initiate Phase 2 clinical trials in patients with hypertrophic cardiomyopathy (HCM) and ventricular tachycardia and ventricular fibrillation (VT/VF).
