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The purpose of this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections in infants, elderly, and adults with other serious medical conditions.
This study is seeking participants who:
Participants will take the study medicine as capsules by mouth once at the study clinic. The participants will stay at the study clinic for about 5 days. During that time, the study team will monitor the participants. The study team will take some blood samples to test the level of PF-07923568. This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | Participants with severe renal impairment will receive a single oral dose of PF-07923568 |
|
| Cohort 2: Normal Renal Function | Experimental | Participants with normal renal function will receive a single oral dose of PF-07923568 |
|
| Cohort 3 (Optional): Moderate Renal Impairment | Experimental | Participants with moderate renal impairment will receive a single oral dose of PF-07923568 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: PF-07923568 | Drug | A single dose of PF-07923568 administered orally as 4 capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Baseline through Day 5 | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Baseline through Day 5 | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Baseline through Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline through Day 36 | |
| Number of Participants With Change From Baseline in Laboratory Tests Results | Baseline through Day 5 |
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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 |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | 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 |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000717948 | sisunatovir |
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|
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline through Day 5 |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs) | Baseline through Day 5 |
| Tampa |
| Florida |
| 33603 |
| United States |
| Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78212 | United States |
| Clinical Trials of Texas, LLC dba Flourish Research | San Antonio | Texas | 78229 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |