A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet

Exclusion Criteria

• •history of significant sensitivity to any drug;
• •positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab;
• •history of gastrointestinal issues or procedures;
• •history of seizures, diabetes or cancer (except basal cell carcinoma);
• •clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
• •use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
• •donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
• •clinically significant abnormal screening laboratory analyses and ECGs:
• •* ALT \> ULN,
• •* AST \> ULN,
• •* ECG with QTcF\>450 msec in females and \>430 msec in males,
• •* or ECG with 2nd or 3rd degree atrioventricular block;
• •current enrollment in another clinical study;
• •previous enrollment in this study;
• •recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
• •pregnant or breastfeeding female;
• •requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis or use within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication;
• •use of known inhibitors or inducers of cytochrome P450 3A or cytochrome P450 2C8 within 1 month prior to study drug administration;
• •positive screen for drugs of abuse, alcohol, or cotinine;
• •receipt of any drug by injection within 30 days prior to study drug administration;
• •receipt of any investigational product within a time period equal to 10 half-lives of the product or a minimum of 6 weeks prior to study drug administration;
• •consumption of alcohol within 48 hours prior to study drug administration;
• •consumption of grapefruit, grapefruit products, star fruit, or star fruit products within the 72-hour period prior to study drug administration;
• •consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-333;
• •history of cardiac disease, including family history of long-QT syndrome or unexplained sudden death.