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The purpose of this clinical trial is to learn about the safety and pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from body after participant take it) of the study medicine (called PF-08057418) in healthy people.
This study is seeking participants who are healthy adults.
Everyone who participates in this study will receive the study medicine. The study medicine may be given as a solution or as a tablet. Participants will be dosed once a week for 5 weeks.
The investigator will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe.
Participants will be involved in this study for up to 13 weeks from screening to follow-up visit. Participants stay in the study clinic for the 5 week dosing duration of the study, with two follow-up visits subsequently, either in person or by telephone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-08057418 | Experimental | Participants will receive single oral solution or tablet dose(s) of PF-08057418 |
|
| Placebo | Placebo Comparator | Participants will receive single oral solution or tablet dose(s) of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08057418 | Drug | solution or tablet (fasted/fed) |
| |
| Placebo (A placebo does not have any medicine in it but looks just like the medicine being studied.) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Assessment of TEAEs, SAEs, clinical laboratory values, vital signs, continuous cardiac monitoring and 12-lead ECGs | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area under the concentration-time curve (AUC) of PF-08057418 | Up to 10 weeks | |
| PK: Maximum Observed Plasma Concentration (Cmax) of PF-08057418 | Up to 10 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
History or evidence of clinically significant medical conditions, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases (excluding untreated, asymptomatic seasonal allergies at the time of dosing).
Any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy).
History of HIV infection, hepatitis B, or hepatitis C, or positive screening tests for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is permitted.
History of phototoxicity or photosensitivity.
Prior use of any investigational drug or vaccine within 30 days or 5 half-lives (whichever is longer) before the first study dose, or participation in another investigational study during this study.
Elevated blood pressure at screening:
Renal impairment, defined as estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m².
Clinically significant ECG abnormalities, including but not limited to QT corrected for heart rate by Fridericia's cube root formula (QTcF) >450 ms, complete left bundle branch block, evidence of myocardial infarction or ischemia, second- or third-degree AV block, or clinically significant arrhythmias.
Clinically significant laboratory abnormalities at screening, including ALT, AST, or total bilirubin ≥1.05 × ULN (participants with Gilbert's syndrome may be eligible if direct bilirubin is ≤ULN).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit -New Haven | Recruiting | 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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| Other |
solution or tablet (fasted/fed) |
|
| PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-08057418 |
| Up to 10 weeks |