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

NCT05690932 | Completed Phase 1 FDA Drug

• 1 other identifier: PBI-200-105
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Formulation Bridging; Food Effect

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  8 days

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

  8 days

• Incidence, frequency and severity of adverse events (AEs)

  14 days

Study Arms (6)

Capsule

EXPERIMENTAL

Study drug will be administered with water after an overnight fast.

Drug: PBI-200 Capsule

Tablet

EXPERIMENTAL

Study drug will be administered with water after an overnight fast.

Drug: PBI-200 Tablet

Suspension

EXPERIMENTAL

Study drug will be administered with water after an overnight fast.

Drug: PBI-200 Suspension

Fasted

EXPERIMENTAL

Study drug will be administered with water after an overnight fast.

Drug: PBI-200 Tablet

Low-fat Meal

EXPERIMENTAL

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

High-fat Meal

EXPERIMENTAL

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

Interventions

PBI-200 Tablet DRUG

Single dose of PBI-200 tablet

Fasted; High-fat Meal; Low-fat Meal; Tablet

PBI-200 Capsule DRUG

Single dose of PBI-200 capsule

Capsule

PBI-200 Suspension DRUG

Single dose of PBI-200 suspension

Suspension

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pyramid Biosciences: lead

Study Sites (1)

Bio-Kinetic Clinical Applications

Springfield, Missouri, 65802, United States

Location

Study Officials

• Chief Medical Officer

  Pyramid Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-dose, open-label, randomized, three-way crossover design

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: February 24, 2022
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)