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The purpose of the study is to learn about:
These participants will have different levels of kidney function loss:
This study is seeking for participants who:
About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing.
On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. 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 renal impairment |
|
| Cohort 2 | Experimental | Severe renal impairment |
|
| Cohort 3 | Experimental | Moderate renal 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 5 |
| Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf) | Plasma PF-07817883 PK parameters | Day 1 to Day 5 |
| Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) | Plasma PF-07817883 parameters | Day 1 to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Non-Serious Adverse Events (NSAE) | Safety Parameter | Screening to Day 35 |
| Number of participants with Treatment Emergent Adverse Events | Safety Parameter |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Genesis Clinical Research, LLC |
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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 |
| D051437 | Renal Insufficiency |
| 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 | Day 1 to Day 5 |
| Number of participants with Clinically Significant Abnormal Vital Signs | Day 1 to Day 5 |
| Number of participants with Clinically Significant abnormal laboratory values. | Baseline to Day 5 |
| Number of participants with Serious Adverse Events | Safety parameters | Screening to Day 35 |
| Tampa |
| Florida |
| 33603 |
| United States |
| Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota | 55114 | 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 |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |