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

Pyramid Biosciences33 enrolled

Overview

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.

This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Formulation Bridging Food Effect

Interventions

PBI-200 TabletDRUG

Single dose of PBI-200 tablet

PBI-200 CapsuleDRUG

Single dose of PBI-200 capsule

PBI-200 SuspensionDRUG

Single dose of PBI-200 suspension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bio-Kinetic Clinical Applications

Springfield, Missouri, United States

Outcomes

Primary Outcomes

Maximum Plasma Concentration [C(max)] of PBI-200

Maximum (peak) plasma drug concentration

Time frame: 8 days

Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of th 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.

Time frame: 8 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.

Time frame: 8 days

Secondary Outcomes

Time to Maximum Concentration [T(max)] of PBI-200

T(max) will be determined from the observed plasma concentration data

Time frame: 8 days

Terminal elimination half-life [T(1/2)]

Apparent terminal elimination half-life, calculated as ln(2)/kel

Time frame: 8 days

Incidence, frequency and severity of adverse events (AEs)

Time frame: 14 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.