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NCT07172321CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 17 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
12 (actual)
First submitted
28 Aug 2025
Start date
5 Sept 2025
Primary completion date
4 Oct 2025
Lead sponsor
Pfizer
NCT number
NCT07172321

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 12
  • From 5 Sept 2025 to the primary completion date, 4 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of certain prescription or nonprescription drugs and dietary (e.g. grapefruit) and herbal supplements within up to 14 days or 5 half-lives, whichever is longer, prior to the first dose of study intervention.
  • Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
  • Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).

Other illness

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
    • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
    • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBsAb, HBcAb, or HCVAb. A positive HBsAb result and a history of Hepatitis B vaccination is allowed.
  • History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.

Who the study is looking for

  • Male and female participants of non-childbearing potential ≥18 years of age
  • BMI of 16-32 kg/m2; and a total body weight \>45 kg (99 lbs)
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pfizer Clinical Research Unit - New Haven
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.