Date: 2015-01-06
Type of
information: Completion of the trial
phase:
Announcement: completion of the trial
Company: Genfit (France)
Product: GFT505
Action
mechanism: PPAR agonist. Elafibranor (GFT505) is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways to treat nonalcoholic steatohepatitis (NASH). Elafibranor is believed to address mutliple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers.
Disease:
Therapeutic
area: Metabolic diseases - Liver diseases
Country:
Trial
details:
Latest
news:
- • On January 6th, 2015, Genfit announced the company successfully completed a thorough QT/QTc cardiac safety study of GFT505. In accordance with regulatory guidance (ICH E14) on the evaluation of the cardiac safety of products under development, the potential effects of GFT505 on the electrical activity of the heart were assessed. In the study, 168 healthy volunteers were divided into four groups: placebo, GFT505 at 120mg/day (therapeutic dose), GFT505 at 300mg/day (supratherapeutic dose), and moxifloxacin at 400mg (positive control). The electrical activity of the heart (electrocardiogram) was continuously monitored over a 24-hour period before and at the end of the 14-day treatment period. The data showed that repeated daily administration of GFT505 dosed up to 2.5 fold higher than the therapeutic dose had no effect on cardiac electrical activity. In particular, the ventricular contraction time (measured by the QT interval of the electrocardiogram) was not altered. Doses of 120mg/day and 300mg/day were well tolerated in the study.
Is
general: Yes
