Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers

Exclusion Criteria

• •History of serious adverse reactions or hypersensitivity to any drug.
• •Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
• •Background or clinical evidence of chronic diseases.
• •Acute illness two weeks before drug administration.
• •Having undergone major surgery during the previous 6 months.
• •History of alcohol or drug abuse in the last 5 years.
• •Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
• •Need of any prescription medication within 14 days prior to the administration of the drug and non prescription medication or herbal medicines within 7 days prior to the administration of the drug.
• •Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested.
• •Not having donated blood during 3 month period before inclusion in the study.
• •Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
• •12 lead ECG obtained at screening with PR \> 220 msec, QRS\>120 msec and QTc \>440 msec, bradycardia (\<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG.
• •Symptoms of a significant somatic or mental illness in the four week period preceding drug administration.
• •History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
• •Positive results from the HIV serology.
• •Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation.
• •Positive results of the drug screening the day before starting treatment period.
• •Known hypersensitivity to the study drug or the composition of the galenical form
• •History of psychiatric diseases or epileptic seizures