 - Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal such as significant diarrhea, gastric stasis, or constipation that in the Investigators opinion could influence drug absorption or bioavailability, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances 