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

A Single-Dose, Open-Label, Two-Part, Randomized, 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 and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Formulation Bridging and Food Effect in Healthy Volunteers
• Intervention / Treatment: Drug: PBI-200 Capsule; Drug: PBI-200 Tablet; Drug: PBI-200 Suspension

Detailed Description

This is a singl-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
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Fredericia's formula (QTcF) prolongation over 450 milliseconds at Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsule; Study drug will be administered with water after an overnight fast.	Drug: PBI-200 Capsule; Single dose of PBI-200 capsule
Experimental: Tablet; Study drug will be administered with water after an overnight fast.	Drug: PBI-200 Tablet; Single dose of PBI-200 tablet
Experimental: Suspension; Study drug will be administered with water after an overnight fast.	Drug: PBI-200 Suspension; Single dose of PBI-200 suspension
Experimental: Fasted; Study drug will be administered with water after an overnight fast.	Drug: PBI-200 Tablet; Single dose of PBI-200 tablet
Experimental: Low-fat Meal; 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 Tablet; Single dose of PBI-200 tablet
Experimental: High-fat Meal; 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 Tablet; Single dose of PBI-200 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration [C(max)] of PBI-200	Maximum (peak) plasma drug concentration	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.	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.	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Maximum Concentration [T(max)] of PBI-200	T(max) will be determined from the observed plasma concentration data	8 days
Terminal elimination half-life [T(1/2)]	Apparent terminal elimination half-life, calculated as ln(2)/kel	8 days
Incidence, frequency and severity of adverse events (AEs)		14 days

Collaborators and Investigators

• Sponsor: Pyramid Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): May 23, 2022
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PBI-200-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No