ACH15Phase I, Monocentric, Double-blind, Randomized Study to Assess Tolerability, Safety and Pharmacokinetics of ACH15 After Single Dose and Multiple Doses in Healthy Male Volunteers

Date de début de l'étude : 1 mai 2015

Inclusion Criteria: Male patient, aged between 18 and 50 years; Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and ≤ 30 kg/m2; Healthy men accordance with their historical and tests; Healthy subject with laboratory results within the normal range or within the parameters accepted by the clinical protocol Negative results for parasitological stool examination performed in the clinical study; Subject of research with laboratory results within the normal range for urinalysis collected before the first visit; Research subjects allocated in Group 6 with endoscopy within the normal range; Exclusion Criteria: History of gastrointestinal disease, hepatic, renal, cardiovascular, pulmonary, neurologic, hematologic, diabetes or glaucoma; Evidence on clinical examination or physical or complement, organ dysfunction or any clinically significant deviation from normality; History of use of psychotropic drugs or excessive alcohol consumption (more than two units of alcohol per day, one unit being equivalent to one cup (200 mL) of brew or a dose (50) mL of distilled beverage) or having difficulty to abstain during the study; Use of any medication two (2) weeks prior to inclusion of the research subject in the study; Regular smokers or who quit less than one (1) year; History of food allergy or hyperreactivity to medications or foods; HIV positive for HIV; Being positive for Hepatitis B; Being positive for hepatitis C; Testing positive for Helicobacter pilorum; Using substances modulating hepatic microsomal activity within thirty (30) days prior to entry of the subject of research in the clinical study (date of signing the consent form); Having donated blood (blood volume higher than 500 mL) within four (4) months preceding the date of signing the consent form; Subject with a history of hypersensitivity to any component of the investigational product;