Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy Volunteers
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase
I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating
its effect on QT/QTc prolongation in healthy male and female subjects. According to the
guidelines, such studies should typically be performed at the expected therapeutic dose and a
supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.
GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy
overweight subjects (study GFT505-111-7), and both safety and tolerability were very good.
However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d.
Therefore, the current TQT study will be preceded by a multiple ascending dose study in which
the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding to 2.5
and 3 times the expected therapeutic dose will be evaluated. The highest dose level for which
safety and tolerability are considered satisfactory will be the supra-therapeutic dose used
in the TQT study.
Phase:
Phase 1
Details
Lead Sponsor:
Genfit
Collaborators:
CardiaBase Eurofins Optimed PHINC DEVELOPMENT
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination