First-in-Human Trial of Oral AN2-502998

Exclusion Criteria23

• History of significant sensitivity to any drug, including any excipients used in AN2-502998
• Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements
• Use of any medications (prescription or over-the-counter), vitamins, and/or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 5 half-lives of the respective medication, whichever is longer
• Receipt of any drug by injection, including vaccinations, within 30 days (for vaccinations) or a period defined by 5 half-lives, whichever is longer, prior to study drug administration
• If female, is pregnant or breastfeeding
• Positive test result for HBsAg, HCV Ab, HIV Ab, or HIV Ag at Screening; negative HIV status will be confirmed at Screening
• ALT, AST, or total bilirubin with direct bilirubin >ULN for the reference laboratory at Screening
• CrCl (Cockcroft-Gault formula), Hgb, Hct, WBC, neutrophil, or platelet count <LLN for the reference laboratory at Screening, unless deemed not CS by the Investigator
• Fasting glucose ≥5.6 mmol/L
• QTcF interval duration >450 msec for females or >430 msec for males at Screening
• Recent (3-month) history of drug or alcohol abuse that could preclude adherence to the protocol
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer, or 1.5 ounces \[45 mL\] of hard liquor) within 6 months prior to Screening
• Positive screen for drugs of abuse, alcohol, or cotinine at Screening and Study Day -1
• History of seizures, diabetes, or cancer (except basal cell carcinoma of the skin)
• Current clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or thyroid disease, or any uncontrolled medical illness or psychiatric disease or disorder
• Past history of epilepsy; any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic, or thyroid disease; or any uncontrolled medical illness or psychiatric disease or disorder
• History of gastric surgery, vagotomy, bowel resection, cholecystectomy, or any surgical procedure or medical condition that might interfere with gastrointestinal motility, pH, or absorption
• Donation or loss of 550 mL or more blood volume (including plasmapheresis) within 4 weeks prior to study drug administration or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
• Receipt of any investigational product within a period equal to 10 half-lives of the product, if known, or a minimum of 6 weeks prior to study drug administration
• Consumption of alcohol within the 72 hours prior to study drug administration
• Consumption of grapefruit, star fruit, Seville oranges, or products containing any of these ingredients within the 10-day period prior to study drug administration
• Use of inhaled nicotine, tobacco, or marijuana products within the 6 months prior to study drug administration
• Current enrollment in another clinical trial