Clinical trial NCT01474161 (phase 1, status: completed)
Conditions: type 2 diabetes, diabetes mellitus, type 2, metabolic diseases, cardiovascular diseases, obese, dyslipidemia
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44, Z86.39, O99.280, O99.281, O99.282, O99.283, O99.284, O99.285, A52.00, A52.09, A50.54, Z01.810, Q87.418, Z13.6, R94.30
Drugs: gft505 120mg - old formulation, gft505 120mg - new formulation, gft505 180mg - new formulation, gft505 240mg - new formulation, gft505 300mg - new formulation, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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.