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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2022-05-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Formulation Bridging Food Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Capsule

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

Group Type EXPERIMENTAL

PBI-200 Capsule

Intervention Type DRUG

Single dose of PBI-200 capsule

Tablet

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

Group Type EXPERIMENTAL

PBI-200 Tablet

Intervention Type DRUG

Single dose of PBI-200 tablet

Suspension

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

Group Type EXPERIMENTAL

PBI-200 Suspension

Intervention Type DRUG

Single dose of PBI-200 suspension

Fasted

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

Group Type EXPERIMENTAL

PBI-200 Tablet

Intervention Type DRUG

Single dose of PBI-200 tablet

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.

Group Type EXPERIMENTAL

PBI-200 Tablet

Intervention Type DRUG

Single dose of PBI-200 tablet

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.

Group Type EXPERIMENTAL

PBI-200 Tablet

Intervention Type DRUG

Single dose of PBI-200 tablet

Interventions

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PBI-200 Tablet

Single dose of PBI-200 tablet

Intervention Type DRUG

PBI-200 Capsule

Single dose of PBI-200 capsule

Intervention Type DRUG

PBI-200 Suspension

Single dose of PBI-200 suspension

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes