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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-Dose, Open-Label, Randomized, Three-Way, Crossover Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers

Conditions
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Food Effect in Healthy Volunteers

Intervention / Treatment
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* Drug: PBI-200


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single-dose, open-label, randomized, three-way crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasted<br>Study drug will be administered with water, after an overnight fast. | Drug: PBI-200<br>* Single dose of PBI-200<br>|
| Experimental: Low-fat Meal<br>Study drug will be administered with water, after an overnight fast, after which time a standard low-fat breakfast will be given. | Drug: PBI-200<br>* Single dose of PBI-200<br>|
| Experimental: High-fat Meal<br>Study drug will be administered with water, after an overnight fast, after which time a standard high-fat breakfast will be given. | Drug: PBI-200<br>* Single dose of PBI-200<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Concentration [T(max)] of PBI-200 | Tmax will be determined from the observed plasma concentration data. | 7 days | 
| Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last measurable concentration [AUC(0-t)] | AUC, calculated using linear up/ log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration. | 7 days | 
| AUC of PBI-200 from time zero to infinity [AUC(0-inf)] | AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/ kel, where kel is the terminal rate constant and Ct is the last measurable concentration. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of the maximum observed drug concentration [T(max)] | Time of the maximum observed drug concentration | 7 days | 
| Terminal elimination half-life [T(1/2)] | Apparent terminal elimination half-life, calculated as ln(2)/ kel. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volunteer