Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505

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.

Conditions

• Type 2 Diabetes
• Diabetes Mellitus, Type 2
• Metabolic Diseases
• Cardiovascular Diseases
• Obese
• Dyslipidemia

Interventions

DRUG

GFT505 120mg - old formulation

hard gelatin capsules dosed at 60mg, one single oral administration (Study part I), 6 capsules with 250mL of water.

DRUG

GFT505 120mg - new formulation

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.

DRUG

GFT505 180mg - new formulation

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.

DRUG

GFT505 240mg - new formulation

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.

DRUG

GFT505 300mg - new formulation

hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II), 5 capsules with 250mL of water.

DRUG

Placebo

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).

Sponsors & Collaborators

• SGS Aster S.A.S.

  collaborator UNKNOWN

• Naturalpha

  collaborator INDUSTRY

• Genfit

  lead INDUSTRY

Principal Investigators

• Rémy Hanf, Development Director · GENFIT, France

• Philippe Betting, MD · SGS Aster S.A.S., Phase I Clinical Unit, France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2012-11-30

Completion

2012-11-30

Countries

• France

Study Locations