Study of AC0058TA in Healthy Male and Female Subjects

Exclusion Criteria

• •Has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune suppressive/defective, or psychiatric disorder as determined by the Investigator;
• •Has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
• •Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (a subject who has had an appendectomy or hernia repair may be enrolled in the study);
• •Has a history of congenital nonhemolytic hyperbilirubinaemia (eg, Gilbert's syndrome);
• •Has a history of alcoholism or drug addiction within 1 year prior to Check-in;
• •Has a positive test for selected drugs of abuse at Screening (not including alcohol) or Check-in (including alcohol);
• •Has a positive hepatitis panel and/or positive human immunodeficiency virus (HIV) antibody screens;
• •Has a positive pregnancy test result at Screening or Check-in (females only);
• •Has clinically significant findings as determined by the Investigator (eg, medical history, 12-lead ECG, vital signs, or clinical laboratory evaluations;
• •Has participated in any other investigational drug trial in which receipt of an investigational drug (new chemical entity) occurred within 5 half-lives of the respective study drug or 30 days prior to Check-in, whichever is longer;
• •Has used any medications/products, including St. John's Wort, known to alter drug absorption or elimination processes within 30 days prior to Check-in, unless deemed acceptable by the Investigator;
• •Has used any prescription medications/products not discussed in another exclusion criterion within 14 days prior to Check-in, unless deemed acceptable by the Investigator;
• •Has used slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator; 14. Has used any over-the-counter, nonprescription medications/products not discussed in another exclusion criterion (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the Investigator;
• •Has donated blood within 30 days prior to Screening, plasma within 2 weeks prior to Screening, or platelets within 6 weeks prior to Screening;
• •Has received blood products within 2 months prior to Check-in;
• •Has poor peripheral venous access;
• •Who, in the opinion of the Investigator, should not participate in this study.