NCT06122194

A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.

Detailed description

This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Drug: PF-07817883	PF-07817883 tablet

Timeline

• Start date: 2023-11-23
• Primary completion: 2024-01-12
• Completion: 2024-01-12
• First posted: 2023-11-08
• Last updated: 2025-01-30
• Results posted: 2025-01-30

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study