NCT05160389

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

A Single-Dose, Open-Label, Randomized, Three-Way, Crossover Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pyramid Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Food Effect in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PBI-200	Single dose of PBI-200

Timeline

• Start date: 2021-11-17
• Primary completion: 2022-01-06
• Completion: 2022-01-06
• First posted: 2021-12-16
• Last updated: 2022-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study