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

Pyramid Biosciences

Status and phase: Completed; Phase 1

Conditions: Food Effect; Formulation Bridging

Treatments: Drug: PBI-200 Capsule; Drug: PBI-200 Suspension; Drug: PBI-200 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05690932

PBI-200-105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 6 patient groups

Capsule

Experimental group

Description:

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

Treatment:

Drug: PBI-200 Capsule

Tablet

Experimental group

Description:

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

Treatment:

Drug: PBI-200 Tablet

Suspension

Experimental group

Description:

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

Treatment:

Drug: PBI-200 Suspension

Fasted

Experimental group

Description:

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

Treatment:

Drug: PBI-200 Tablet

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 Tablet

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 Tablet