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

Sponsor

Pyramid Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT05690932

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Formulation Bridging Food Effect	Drug: PBI-200 Tablet Drug: PBI-200 Capsule Drug: PBI-200 Suspension	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Single-dose, open-label, randomized, three-way crossover designSingle-dose, open-label, randomized, three-way crossover design

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 24, 2022

Actual Primary Completion Date :

May 23, 2022

Actual Study Completion Date :

May 23, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Maximum Plasma Concentration [C(max)] of PBI-200 [8 days]
Maximum (peak) plasma drug concentration
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of th last measurable concentration [AUC(0-t)] [8 days]
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.
AUC of PBI-200 from time zero to infinity [AUC(0-inf)] [8 days]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bio-Kinetic Clinical Applications	Springfield	Missouri	United States	65802

Sponsors and Collaborators

Pyramid Biosciences

Investigators

Study Director: Chief Medical Officer, Pyramid Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pyramid Biosciences

ClinicalTrials.gov Identifier:

NCT05690932

Other Study ID Numbers:

PBI-200-105

First Posted:

Jan 19, 2023

Last Update Posted:

Feb 1, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 1, 2023