A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of Genz-682452 With a Pilot Investigation of Food Effect in Healthy Adult Male Subjects.

Fecha de inicio: 1 de agosto de 2012

Inclusion Criteria: Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m^2, inclusive. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Exclusion Criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. Frequent headaches and/or migraine, recurrent nausea and/or vomiting. Blood donation, greater than 100 mL, within 2 months before inclusion. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. History or presence of drug or alcohol abuse. Unable to stop smoking cigarettes during the study. Excessive consumption of beverages containing xanthine bases.