A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers

This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.

Inclusion Criteria:Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive).Body Mass Index (BMI) between 18.0 and 32.0 kg/m² (inclusive).Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.Exclusion Criteria:History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).Intolerance to repeated venipuncture.Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.Volunteers with a corrected QT using Fridericia's formula (QTcF) prolongation over 450 milliseconds at Screening.