Atopic DermatitisPhase 1NCT07172321
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 study testing PF-08049820 MR1, PF-08049820 MR2 and PF-08049820 IR in people with Atopic Dermatitis, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PF-08049820 MR1, PF-08049820 MR2 and PF-08049820 IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to 29 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official 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
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.
Read more
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
- Being tested
- PF-08049820 MR1, PF-08049820 MR2, PF-08049820 IR
- Keywords
- Healthy Volunteer
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08049820 MR1Drug
Administered orally
PF-08049820 MR2Drug
Administered orally
PF-08049820 IRDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will receive a single dose of PF-08049820 short Modified release (MR) release rate (MR1) tablets under fasted conditions. Receives: 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. Receives: Drug: PF-08049820 MR2 |
| Treatment C | Experimental | Participants will receive a single dose of PF-08049820 Immediate Release (IR) tablets under fasted conditions. Receives: Drug: PF-08049820 IR |
| Treatment D | Experimental | Participants will receive a single dose of PF-08049820 MR2 tablets under fed conditions. Receives: Drug: PF-08049820 MR2 |
| Treatment E | Experimental | Participants will receive a single dose of PF-08049820 IR tablets under fed conditions. Receives: Drug: PF-08049820 IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of PF-08049820 in the fasted state
Measured: Pre-dose until 72 hours post dose
PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fasted state
Measured: 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
Measured: Pre-dose until 72 hours post dose
PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fed state
Measured: Pre-dose until 72 hours post dose
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: First dose, up to follow up visit (28-35 days post last dose)
Number of Participants With Clinical Laboratory Abnormalities
Measured: Baseline, up to Day 16
Number of Participants With Vital Signs Abnormalities
Measured: Baseline, up to Day 16
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Measured: Baseline, up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start5 Sep 2025
- Primary completion4 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172321
- Sponsor's protocol ID
- C6231007
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07172321
- Acronym / sponsor ID
- C6231007
- Conditions
- Atopic Dermatitis
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: PF-08049820 MR1Participants will receive a single dose of PF-08049820 short Modified release (MR) release rate (MR1) tablets under fasted conditions. |
| Treatment B | Experimental | Drug: PF-08049820 MR2Participants will receive a single dose of PF-08049820 long MR release rate (MR2) tablets under fasted conditions. |
| Treatment C | Experimental | Drug: PF-08049820 IRParticipants will receive a single dose of PF-08049820 Immediate Release (IR) tablets under fasted conditions. |
| Treatment D | Experimental | Drug: PF-08049820 MR2Participants will receive a single dose of PF-08049820 MR2 tablets under fed conditions. |
| Treatment E | Experimental | Drug: PF-08049820 IRParticipants will receive a single dose of PF-08049820 IR tablets under fed conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-08049820 MR1Administered orally | Drug | Treatment A |
| PF-08049820 MR2Administered orally | Drug | Treatment B, Treatment D |
| PF-08049820 IRAdministered orally | Drug | Treatment C, Treatment E |
Primary outcome
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
PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fasted state
Time frame: Pre-dose until 72 hours post dose
6 secondary outcomes
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
PK: Plasma Maximum Concentration (Cmax) of PF-08049820 in the fed state
Time frame: Pre-dose until 72 hours post dose
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)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline, up to Day 16
Number of Participants With Vital Signs Abnormalities
Time frame: Baseline, up to Day 16
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline, up to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-08049820 MR1, PF-08049820 MR2 and PF-08049820 IR in people with Atopic Dermatitis, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.