Clinical Trials Directory

Trials / Completed

CompletedNCT07172321

A Study to Learn How Different Forms of the Study Medicine Called PF 08049820 Are Taken up Into the Bloodstream in Healthy Adults

A Phase 1, Open-Label, Randomized, 5-Period, 6-Sequence, Crossover Study to Compare the Single-Dose Pharmacokinetics of One Immediate-Release and Two Modified-Release Formulations of PF-08049820 Administered Orally to Healthy Adult Participants Under Fasted and Fed Conditions

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 see how different forms of a medicine called PF-08049820 move through the body when taken by mouth. The scientists want to see: * How well is the medicine absorbed when it's made in different ways (fast vs. slow release) * If eating a high-fat meal changes how the medicine moves through the body The results of this study will help decide which version of the medicine is best for future studies. This study is seeking participants who: * are men and women who can't have children * are 18 years or older * weigh more than 99 pounds (45 kg) * have a healthy body weight (not too low or too high) * are generally healthy with no serious medical problems. People with serious health problems, recent drug use, or who had certain vaccines recently cannot join. * are willing to follow all the study rules Each participant will try 5 different versions of the medicine, one at a time. There will be 3 days between each dose to make sure the medicine is out of the system. The medicine will be tested in different forms: * Immediate-release tablet (works quickly) * Short-release tablet (works slowly) * Long-release tablet (works even slower) Some versions will be taken without food, and others after eating a high-fat meal. After each dose, doctors will take blood samples for up to 72 hours to see how the medicine moves through the body. The whole study will take about 6 to 11 weeks and participants will stay overnight in the clinic for about 17 days.

Conditions

Interventions

TypeNameDescription
DRUGPF-08049820 MR1Administered orally
DRUGPF-08049820 MR2Administered orally
DRUGPF-08049820 IRAdministered orally

Timeline

Start date
2025-09-05
Primary completion
2025-10-04
Completion
2025-10-29
First posted
2025-09-15
Last updated
2025-11-17

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07172321. Inclusion in this directory is not an endorsement.