NCT05690932

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

A Single-Dose, Open-Label, Two-Part, Randomized, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Pyramid Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Formulation Bridging
• Food Effect

Interventions

Type	Name	Description
DRUG	PBI-200 Tablet	Single dose of PBI-200 tablet
DRUG	PBI-200 Capsule	Single dose of PBI-200 capsule
DRUG	PBI-200 Suspension	Single dose of PBI-200 suspension

Timeline

• Start date: 2022-02-24
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2023-01-19
• Last updated: 2023-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study