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This clinical study is designed to evaluate a study medicine called PF-08049820. The main aim is to understand how the body processes this medicine and whether giving it with another medicine, rabeprazole, affects how it behaves.
The study will take in healthy adult participants aged 18 to 65 years who are not able to have children. Eligible participants must weigh more than 50 kilograms (110 pounds) and have a Body Mass Index (BMI) between 18.5 and 27.9.
Each participant will receive two treatments:
Both medicines will be taken by mouth. Participants will stay at the study clinic for a few days during each treatment period. During these stays, the study team will collect blood samples to see how the body absorbs and processes the medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive single oral dose of PF-08049820. |
|
| Treatment B | Experimental | Participants will receive rabeprazole for 5 days followed by a single oral dose of PF-08049820 and rabeprazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08049820 | Drug | Oral tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08049820. | Day 1 through Day 38-45 | |
| PK: Area under the plasma concentration (AUC) of PF-08049820 | Day 1 through Day 38-45 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events | First dose through Day 38-45 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital Affiliate of Capital University | Beijing | Beijing Municipality | 100050 | China | ||
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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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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole |
| Drug |
Oral tablets |
|
|
| Beijing Friendship Hospital Affiliate of Capital University |
| Beijing |
| Beijing Municipality |
| 101100 |
| China |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |