Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers

Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers.

This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.

Inclusion:

• Healthy male subject, aged between 18 and 45 years inclusive
• Certified as healthy by a comprehensive clinical assessment
• Normal dietary habits
• Normal ECG recording on a 12-lead ECG
• Signing a written informed consent prior to selection

Exclusion:

• Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
• Frequent headaches and / or migraine, recurrent nausea and / or vomiting
• Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
• Blood donation (including in the frame of a clinical trial) within 2 months before administration
• General anaesthesia within 3 months before administration
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
• Inability to abstain from intensive muscular effort
• No possibility of contact in case of emergency
• Any drug intake (except paracetamol or contraception) during the last month prior to the first administration
• History or presence of drug or alcohol abuse (alcohol consumption > 30 grams / day)
• Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day)
• 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
• Positive results of screening for drugs of abuse
• 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
• Administrative or legal supervision