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| ID | Type | Description | Link |
|---|---|---|---|
| C4921014 | Other Identifier | Pfizer |
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The purpose of this study is to learn how the study medicine PF-07328948 is processed by the body and how safe and tolerable it is in adults with different levels of kidney function.
The study will include participants who:
All participants will receive a single dose of PF-07328948 as a tablet taken by mouth. Participants will stay at a clinical research unit for about 6 days to receive the study medicine and undergo safety checks. Total participation lasts up to 64 days, including screening, inpatient stay, and a follow-up call.
The study is not randomized or blinded, meaning all participants and study staff know which treatment is being given. Group assignment is based on kidney function tests done during screening. The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: PF-07328948 participants without renal impairment | Experimental | Participants without renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
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| Group 2: PF-07328948 participants with severe renal impairment | Experimental | Participants with severe renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
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| Group 3: PF-07328948 participants with moderate renal impairment | Experimental | Participants with moderate renal impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07328948 | Drug | PF-07328948 , 1 tablet orally, once on Day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Fraction of Unbound Drug in Plasma (Fu) of PF-07328948 | Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration). | At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1 |
| Unbound AUCinf (AUCinf,u) of PF-07328948 | AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf,u is the unbound AUCinf. | At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1 |
| Unbound Cmax (Cmax,u) of PF-07328948 | Cmax is the maximum plasma concentration. Cmax,u is the unbound Cmax. | At 0 (prior to dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Day 1 to Day 36 |
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Inclusion Criteria:
Male or female of nonchildbearing potential, between the ages of 18 and 80 years, at the screening visit.
BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lbs).
Stable renal function, defined as ≤25% difference between 2 measurements of eGFR.
Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
Group 1 only: normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from the screening visits.
Groups 2 & 3 only: good general health considered acceptable with the expected health status of individuals with chronic renal impairment.
Groups 2 & 3 only: chronic renal impairment, defined by the following mean eGFR criteria (based on screening visits):
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Orange County Research Center | Recruiting | Lake Forest | California | 92630 | 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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| 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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| Orlando Clinical Research Center |
| Recruiting |
| Orlando |
| Florida |
| 32809 |
| United States |
| Genesis Clinical Research, LLC | Recruiting | Tampa | Florida | 33603 | United States |
| Nucleus Network | Recruiting | Saint Paul | Minnesota | 55114 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |