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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genfit
• Collaborators: Naturalpha; SGS Aster S.A.S.

Criteria

Inclusion Criteria:

Part I :

• Male or female healthy volunteers 18 to 45 years of age (inclusive).

• Subjects with a body mass index (BMI) ≥ 18 and ≤ 28 kg/m2 at screening.

• For female subjects of childbearing potential, use of double contraception method.

• Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator.

Part II and III :

• Male healthy volunteers 18 to 55 years of age (inclusive).

• Subjects with a BMI >28 and <35 kg/m2 at screening.

• Normal arterial BP and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator.

Part IV :

• Male or female Type 2 diabetic patients 18 to 60 years of age.

• Females participating in the study must be either of non-child bearing potential or using an efficient double contraception.

• Currently treated with any antidiabetic treatment (a maximum of two anti-diabetic drugs including metformin in all cases) with the exception of insulin or GLP analogs and agonists therapy.

• Stable diabetes with glycosylated hemoglobin (HbA1c) < or =10% or less.

• Normal renal function as defined by a creatine clearance >90 mL/min calculated with the Cockcroft-Gault formula.

• Subjects with a BMI from 18 to 32 kg/m2 at screening.

Exclusion Criteria:

Part I :

• Who previously received GFT505.

• With any clinically significant abnormality following review of prestudy laboratory tests (Aspartate and Alanine aminotransferase must be within normal ranges), vital signs, full physical examination and Electrocardiogram.

• Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 (Human immunodeficiency virus) or anti-HCV (Hepatitis C virus) antibodies.

• Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol).

• Who drink more than 8 cups daily of beverage containing caffeine.

• Who have a positive laboratory test for urine drug screening (opiates, cocaine, amphetamine, cannabis, benzodiazepines).

• Who have undergone surgery or have donated blood within 12 weeks prior to the start of the study.

• Who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 2 weeks prior to the first dose administration.

Part II and III : specific additional exclusion criteria

• Who have taken fibrates within 6 weeks prior to the first dose administration.

Part IV : specific additional exclusion criteria

• With unstable proliferative retinopathy, macular oedema (fundus examination performed in the previous year will be considered relevant on Investigator's judgement).

• Who have taken fibrates within 6 weeks prior to the first dose administration.