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

Food Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690932
• Other study ID #: PBI-200-105
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2022
• Est. completion date: May 23, 2022

Study information

• Verified date: January 2023
• Source: Pyramid Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Effect

Intervention

Drug:
• PBI-200 Tablet
Single dose of PBI-200 tablet
• PBI-200 Capsule
Single dose of PBI-200 capsule
• PBI-200 Suspension
Single dose of PBI-200 suspension

Locations

Country	Name	City	State
United States	Bio-Kinetic Clinical Applications	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Pyramid Biosciences

Country where clinical trial is conducted

United States, 

Outcome

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