A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200

Launched by PYRAMID BIOSCIENCES · Dec 3, 2021

Keywords

ClinConnect Summary

This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200, administered orally under fasted and fed conditions.

The study will enroll 18 healthy adult volunteers to ensure study completion of at least 12 evaluable volunteers. The study will be conducted in 3 groups, with each group enrolling 6 volunteers. As this is a crossover study, each volunteer will serve as their own control.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive).
• • Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive).
• • Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.
• Key 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 Fredericia's formula (QTcF) prolongation over 450 milliseconds at Screening.