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

NCT07172321 | Completed Phase 1 FDA Drug

• 1 other identifier: C6231007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

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

  Pre-dose until 72 hours post dose

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

  Pre-dose until 72 hours post dose

Secondary Outcomes (6)

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

  Pre-dose until 72 hours post dose

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

  Pre-dose until 72 hours post dose

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

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

• Number of Participants With Clinical Laboratory Abnormalities

  Baseline, up to Day 16

• Number of Participants With Vital Signs Abnormalities

  Baseline, up to Day 16

Study Arms (5)

Treatment A

EXPERIMENTAL

Participants will receive a single dose of PF-08049820 short Modified release (MR) release rate (MR1) tablets under fasted conditions.

Drug: PF-08049820 MR1

Treatment B

EXPERIMENTAL

Participants will receive a single dose of PF-08049820 long MR release rate (MR2) tablets under fasted conditions.

Drug: PF-08049820 MR2

Treatment C

EXPERIMENTAL

Participants will receive a single dose of PF-08049820 Immediate Release (IR) tablets under fasted conditions.

Drug: PF-08049820 IR

Treatment D

EXPERIMENTAL

Participants will receive a single dose of PF-08049820 MR2 tablets under fed conditions.

Drug: PF-08049820 MR2

Treatment E

EXPERIMENTAL

Participants will receive a single dose of PF-08049820 IR tablets under fed conditions.

Drug: PF-08049820 IR

Interventions

PF-08049820 MR1 DRUG

Administered orally

Treatment A

PF-08049820 MR2 DRUG

Administered orally

Treatment B; Treatment D

PF-08049820 IR DRUG

Administered orally

Treatment C; Treatment E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 15, 2025
• Study Start: September 5, 2025
• Primary Completion: October 4, 2025
• Study Completion: October 29, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)