Status:
COMPLETED
A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function
Lead Sponsor:
Pfizer
Conditions:
Renal Impairment
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening.
- Meet the eGFR criteria for cohort placement during the screening period.
- Body mass index (BMI) of 16-40 kg/m2; and a total body weight \>45 kg (99 lb.).
- For Cohort 2 Normal Renal Function Group Only: At screening, meet the demographic-matching criteria, including body weight within ±15 kg and age within ±10 years, of the average of the pooled renal impairment cohort.
Exclusion
- Participants with acute renal disease.
- Participants who are clinically nephrotic.
- Participants requiring hemodialysis.
- Renal allograft recipients.
- Participants who have previously received a kidney, liver, or heart transplant.
- Urinary incontinence without catheterization.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06037031
Start Date
October 30 2023
End Date
July 3 2024
Last Update
July 19 2024
Active Locations (6)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
Genesis Clinical Research, LLC
Tampa, Florida, United States, 33603
3
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States, 55114
4
Clinical Trials of Texas, LLC
San Antonio, Texas, United States, 78212