 - Clinically significant abnormality in past medical history or at the screening physical examination that in the opinion of the PI or Sponsor may place the volunteer at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug, including but is not limited to history or concurrent cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease. 