3. Subjects with past or current diseases of any organ or system (such as, but not limited to, gastrointestinal, cardiac, renal, hepatic that is considered to be clinically significant by the Investigator, in conjunction with the Sponsor's clinical leader or subjects suffering from any condition that can affect the absorption, distribution, metabolism and excretion of orally administered medicines. Subjects with conditions such as non malignant skin diseases and childhood asthma can be included based on the Investigator's discretion and discussed with the Sponsor a priori)