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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:
This study is seeking participants who:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive a single dose of PF-08049820 short Modified release (MR) release rate (MR1) tablets under fasted conditions. |
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| Treatment B | Experimental | Participants will receive a single dose of PF-08049820 long MR release rate (MR2) tablets under fasted conditions. |
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| Treatment C | Experimental | Participants will receive a single dose of PF-08049820 Immediate Release (IR) tablets under fasted conditions. |
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| Treatment D | Experimental | Participants will receive a single dose of PF-08049820 MR2 tablets under fed conditions. |
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| Treatment E | Experimental | Participants will receive a single dose of PF-08049820 IR tablets under fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08049820 MR1 | Drug | Administered orally |
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| PF-08049820 MR2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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).
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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Open label study
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| Drug |
Administered orally |
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| PF-08049820 IR | Drug | Administered orally |
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| 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 |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline, up to Day 16 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |