A Study to Evaluate the Effects of Food on Pharmacokinetics of AC-101

Exclusion Criteria22

• Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies or food intolerances; mild and inactive hay fever is permitted), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug; or place the subject at an unacceptable risk as a participant in this study;
• Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening, minor colds are permitted;
• Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator.
• Taken any drug that inhibits or induces liver drug-metabolizing enzymes 30 days prior to screening; Excessive consumption of special diets (including dragon fruit, mango, grapefruit, grapefruit juice, pomelo, star fruit, Seville oranges, Seville orange marmalade or other products containing grapefruit, pomelo, star fruit or Seville oranges etc.) and/or xanthine-rich diets (including chocolate, tea, coffee, cola, etc.) or other effects that affect the absorption, distribution, metabolism, excretion and other factors of the drug 7 days prior to study drug administration;
• Clinically significant history with sequelae of gastrointestinal tract, liver, kidney, or other diseases known to interfere drug absorption, distribution, metabolism or excretion.
• Prolongation of QTcF (greater than 450 msec for males and greater than 470 msec for females) at screening.
• Known current or history of malignancy.
• Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV) antibody.
• A hospital admission or major surgery within 90 days prior to screening.
• A history of prescription drug abuse, or illicit drug use within 3 months prior to screening.
• A history of alcohol abuse according to medical history within 3 months prior to screening.
• Has more than 5 cigarettes/week within 30 days prior to screening or intends to use any product containing nicotine during the course of the study;
• A positive screen for alcohol, cotinine, and/or drugs of abuse at screening or Day -1.
• An unwillingness or inability to comply with food and beverage restrictions during study participation (ie lactose intolerance; vegans and vegetarians are permitted in Part 1 and 3), and refrain from ingestion of dragon fruit, mango, grapefruit, grapefruit juice, pomelo, star fruit, Seville oranges, Seville orange marmalade or other products containing grapefruit, pomelo, star fruit or Seville oranges from 7 days prior to study drug administration to the end of the study;
• Has had any immunizations (live vaccines) in the 4 weeks prior to screening.
• Has used medications that affect GI motility or gastric emptying within 30 days prior to Day 1.
• Has used any prescription or over-the-counter medication (with exception of acetaminophen at less than 2 g/day until 48 hours prior to dosing), vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days or 5 half-lives of the drug (whichever is longer) prior to Day 1.
• Poor venous access.
• Has lost or donated greater than 450 mL of whole blood or blood products within 30 days prior to screening.
• Taken any investigational drug within 30 days, or 5 half-lives whichever is longer.
• Female who are pregnant, or breastfeeding, Positive pregnancy test result.
• Any condition or finding that in the Investigators’ opinion would put the subject or study conduct at risk if the subject were to participate in the study.