Status:
COMPLETED
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
Lead Sponsor:
Pfizer
Conditions:
COVID-19
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to learn about: * how PF-07817883 is processed in the body of adult participants. * the safety of PF-07817883. These participants will have different levels of kidney fun...
Eligibility Criteria
Inclusion
- Male or female participants aged 18 (or the minimum age of consent in accordance with local regulations) to 90 years of age at screening.
- BMI of ≥16 kg/m2 and a total body weight \>45 kg (99 lbs).
- Stable renal function, defined as the eGFR values obtained at the two screening visits should not be more than 25% different.
Exclusion
- Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -1.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) test due to hepatitis B vaccination is allowed.
- Renal transplant recipients.
- Any condition possibly affecting drug absorption
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06586216
Start Date
September 10 2024
End Date
February 13 2025
Last Update
February 19 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
2
Genesis Clinical Research, LLC
Tampa, Florida, United States, 33603
3
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States, 55114