Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to
compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60
mg GFT505) and the old GFT505 formulation (capsule dosed at 20 mg GFT505) in healthy male
subjects and to assess the impact of gender on this relative bioavailability after
administration in male and female subjects.
Using the new formulation, a single and a multiple ascending dose study will be performed in
overweight or obese male subjects otherwise healthy whose demographic and physiological
characteristics are thought to be closer to those of the target population (Type 2 diabetes).
Thereafter, a group of male and female patients with Type 2 diabetes will receive multiple
dose administration of GFT505.