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

Pyramid Biosciences

Status and phase: Completed; Phase 1

Conditions: Food Effect in Healthy Volunteers

Treatments: Drug: PBI-200

Study type: Interventional

Funder types: Industry

Identifiers

NCT05160389

PBI-200-103

Details and patient eligibility

About

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.

Full description

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, administered orally under fasted and fed conditions.

The study will enroll 18 healthy adult volunteers to ensure study completion of at least 12 evaluable volunteers. The study will be conducted in 3 groups, with each group enrolling 6 volunteers. As this is a crossover study, each volunteer will serve as their own control.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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.

Key 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 Fredericia's formula (QTcF) prolongation over 450 milliseconds at Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Fasted

Experimental group

Description:

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

Treatment:

Drug: PBI-200

Low-fat Meal

Experimental group

Description:

Study drug will be administered with water, after an overnight fast, after which time a standard low-fat breakfast will be given.

Treatment:

Drug: PBI-200

High-fat Meal

Experimental group

Description:

Study drug will be administered with water, after an overnight fast, after which time a standard high-fat breakfast will be given.

Treatment:

Drug: PBI-200