Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
Condition: Type 2 Diabetes; Diabetes Mellitus, Type 2; Metabolic Diseases; Cardiovascular Diseases; Obese; Dyslipidemia
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias; Metabolic Diseases
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The study will be divided in 4 successive parts :

        -  Study Part I will be a comparative bioavailability between a new GFT505 formulation
           (capsule dosed at 60 mg GFT505 by capsule) and the old GFT505 formulation (capsule dosed
           at 20 mg GFT505 by capsule) coupled with an evaluation of the gender effect assessed
           with the new formulation. In this purpose a group of 12 male subjects will receive
           successively both formulations on a unique occasion in a randomized manner while a group
           of 12 female subjects will receive the new formulation on one occasion only. This part
           of the study will be done in healthy volunteers.

        -  Study Part II will be a single ascending dose to be run at a maximum of 3 dose levels.
           Subjects included in this part of the study will receive only one dose level to limit
           the exposure to GFT505. Three cohorts of 8 subjects are planned to be included. This
           part will be run in overweight or obese subjects.

        -  Study Part III will start after completion of the first Cohort of Study Part II. Study
           Part III will be a multiple ascending dose to be run at a maximum of 3 dose levels.
           Subjects included in this part of the study will receive only one dose level to limit
           the exposure to GFT505. Three cohorts of 12 subjects are planned to be included. This
           part will be run in overweight or obese subjects.

        -  Study Part IV will follow the same design and same treatment schedule than Study Part
           III but will be performed in the target population, patients with Type 2 diabetes and
           only one dose will be tested in study part IV.
    

Intervention name(s): GFT505 120mg - old formulation; GFT505 120mg - new formulation; GFT505 180mg - new formulation; GFT505 240mg - new formulation; GFT505 300mg - new formulation; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): hard gelatin capsules dosed at 60mg, one single oral administration (Study part I), 6 capsules with 250mL of water.; hard gelatin capsules dosed at 60mg, one single oral administration (Study Part I) or multiple dose administration from Day 1 to Day 14 (Study Part III and IV), 2 capsules with 250mL of water.; hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II) or multiple dose administration from Day 1 to Day 14 (Study Part III and IV), 3 capsules with 250mL of water.; hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II) or multiple dose administration from Day 1 to Day 14 (Study Part III), 4 capsules with 250mL of water.; hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II), 5 capsules with 250mL of water.; hard gelatin capsules, one single oral administration (3 to 5 capsules with 250mL of water for Study Part II) or multiple dose administration from Day 1 to Day 14 (2 to 4 capsules with 250mL of water for Study Part III).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment