Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets

Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects

The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.

This will be a randomized three-way open cross-over study.

Inclusion Criteria:

1. Healthy male subject, aged 18 to 60 years inclusive;
2. Non-smoker subject or smoker of not more than 5 cigarettes a day ;
3. No history of alcohol or drug abuse
4. Body Mass Index (BMI) between 18 and 27 5 kg/m2 inclusive;
5. Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
6. Signing a written informed consent prior to selection;

Exclusion Criteria:

1. Blood donation (including in the frame of a clinical study) within 2 months before administration;
2. General anaesthesia within 3 months before administration;
3. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
4. Inability to abstain from intensive muscular effort;
5. No possibility of contact in case of emergency;
6. Any drug intake (except paracetamol) during the last month prior to the first administration;
7. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
8. Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day);
9. Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
10. Positive results of screening for drugs of abuse;
11. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
12. Exclusion period of a previous study;
13. Administrative or legal supervision;