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OpenTrials
Completed

NCT Number: NCT07172321

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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).
  • History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.

Treatment and study plan

PF-08049820 MR1

Drug

Administered orally

PF-08049820 MR2

Drug

Administered orally

PF-08049820 IR

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fasted state

    Time frame: Pre-dose until 72 hours post dose

  2. PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fasted state

    Time frame: Pre-dose until 72 hours post dose

Secondary outcomes

  1. PK: Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fed state

    Time frame: Pre-dose until 72 hours post dose

  2. PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fed state

    Time frame: Pre-dose until 72 hours post dose

  3. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: First dose, up to follow up visit (28-35 days post last dose)

  4. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Baseline, up to Day 16

  5. Number of Participants With Vital Signs Abnormalities

    Time frame: Baseline, up to Day 16

  6. Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

    Time frame: Baseline, up to Day 16

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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