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The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups.
This study is seeking participants who:
About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4.
If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing.
The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | No hepatic impairment |
|
| Cohort 2 | Experimental | Mild hepatic impairment |
|
| Cohort 3 | Experimental | Moderate hepatic impairment |
|
| Cohort 4 | Experimental | Severe hepatic impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07817883 | Drug | Experimental |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-07817883 | Plasma PF-07817883 PK parameters | Day 1 to Day 6 |
| Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf) | Plasma PF-07817883 PK parameter | Day 1 to Day 6 |
| Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) | (Optional) Plasma PF-07817883 parameter | Day 1 to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Non-Serious Adverse Events | Safety Parameters | Screening to Day 35 |
| Number of Participants with Treatment Emergent Adverse Events | Safety Parameters |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| National Institute of Clinical Research |
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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 |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Day 1 to Day 35 |
| Number of Participants with Clinically Significant ECG Abnormalities | ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate | Day 1 to Day 6 |
| Number of Participants with Clinically Significant Abnormal Vital Signs | Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate | Day 1 to Day 6 |
| Number of Participants with Clinically Significant Abnormal Laboratory Values | Blood hematology and Chemistry and Urinalysis | Baseline to Day 6 |
| Number of Participants with Serious Adverse Events | Safety Parameters | Screening to Day 35 |
| Garden Grove |
| California |
| 92844 |
| United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Genesis Clinical Research, LLC | Tampa | Florida | 33603 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |