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

NCT05160389 | Completed Phase 1 FDA Drug

• 1 other identifier: PBI-200-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Effect in Healthy Volunteers

Keywords

Volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Time of the maximum observed drug concentration [T(max)]

  7 days

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

  7 days

Study Arms (3)

Fasted

EXPERIMENTAL

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

Drug: PBI-200

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

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

Interventions

PBI-200 DRUG

Single dose of PBI-200

Fasted; High-fat Meal; Low-fat Meal

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 and 32 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 Fredericia'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: December 3, 2021
• First Posted: December 16, 2021
• Study Start: November 17, 2021
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)