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

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

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.

Study Overview

• Status: Completed
• Conditions: Food Effect in Healthy Volunteers
• Intervention / Treatment: Drug: PBI-200

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• 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: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fasted; Study drug will be administered with water, after an overnight fast.	Drug: PBI-200; Single dose of PBI-200
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; Single dose of PBI-200
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; Single dose of PBI-200

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pyramid Biosciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2021
• Primary Completion (ACTUAL): January 6, 2022
• Study Completion (ACTUAL): January 6, 2022

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (ACTUAL): December 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Volunteer
• Other Study ID Numbers: PBI-200-103

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